Johnson & Johnson to Acquire Abiomed

Strengthens Johnson & Johnson's MedTech Business with the Addition of Abiomed,   a World-Leader in Heart Recovery

Transaction to Bring Lifesaving Innovations to More Patients with Unmet Need

Expected to Enhance Johnson & Johnson's Near- and Long-Term Sales and Earnings Growth; Accretive to Adjusted Earnings beginning in 2024

Conference Call at 8:00 a.m. ET To Discuss Details of the Transaction

Johnson & Johnson (NYSE: JNJ), the world's largest, most diversified healthcare products company, and Abiomed (NASDAQ: ABMD), a world leader in breakthrough heart, lung and kidney support technologies, today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire through a tender offer all outstanding shares of Abiomed, for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion which includes cash acquired. Abiomed shareholders will also receive a non-tradeable contingent value right (CVR) entitling the holder to receive up to $35.00 per share in cash if certain commercial and clinical milestones are achieved. The transaction was unanimously approved by both companies' boards of directors.

The transaction broadens Johnson & Johnson MedTech's (JJMT) position as a growing cardiovascular innovator, advancing the standard of care in one of healthcare's largest unmet need disease states: heart failure and recovery. Cardiovascular disease is the number one cause of death. All forms of cardiovascular disease lead to heart failure, which is a significant cost to health systems due to hospitalizations and extended length of stay.

Abiomed is a leading, first-to-market provider of cardiovascular medical technology with a first-in-kind portfolio for the treatment of coronary artery disease and heart failure, an extensive innovation pipeline of life-saving technologies, and an 18-year track record of profitable growth. Abiomed operates in one of the fastest growing medtech segments with significant expansion opportunities in indication, geography, and product.

"The addition of Abiomed is an important step in the execution of our strategic priorities and our vision for the new Johnson & Johnson focused on Pharmaceutical and MedTech," said Joaquin Duato, Chief Executive Officer of Johnson & Johnson. "We have committed to enhancing our position in MedTech by entering high-growth segments. The addition of Abiomed provides a strategic platform to advance breakthrough treatments in cardiovascular disease and helps more patients around the world while driving value for our shareholders."

"Abiomed's skilled workforce and strong relationships with clinicians, along with its innovative cardiovascular portfolio and robust pipeline, complement our MedTech portfolio, global footprint and robust clinical expertise. Together, we have the incredible opportunity to bring lifesaving innovations to more patients around the world," said Ashley McEvoy, Executive Vice President and Worldwide Chairman of MedTech at Johnson & Johnson. "We are committed to investing for growth and look forward to welcoming the talented team and working together to foster our shared patient-first mindset and winning culture of innovation."

"We are pleased to have reached an agreement that reflects the remarkable value Abiomed created with our revolutionary Impella® heart pump platform and promising pipeline," said Michael R. Minogue, Abiomed's Chairman, President and Chief Executive Officer. "This transaction partners us with an organization that shares our patients-first mindset and creates immediate value for our patients, customers, employees and shareholders. It will enable us to leverage Johnson & Johnson's global scale, commercial strength and clinical expertise to accelerate our mission of making heart recovery the global standard of care."

Benefits of the Transaction

  • Diversifies and expands JJMT's portfolio with a leadership platform in heart failure and recovery: Impella® heart pumps – a breakthrough technology with exclusive FDA approvals for patients with severe coronary artery disease requiring high-risk PCI (percutaneous coronary intervention), treatment of AMI (acute myocardial infarction) cardiogenic shock, or right heart failure – will complement JJMT's portfolio, which includes the leading Biosense Webster electrophysiology business, and further accelerate JJMT's shift into high-growth markets.
  • Benefits patients by advancing mission to make heart recovery the global standard of care: Johnson & Johnson's footprint, leading capabilities in physician education, commercial excellence, and robust clinical expertise will complement Abiomed's capabilities, accelerating access and adoption of these lifesaving technologies to more patients around the world.
  • Expands market opportunity through a robust pipeline of technologies and clinical studies: This combination broadens Johnson & Johnson's position as a cardiovascular innovator by adding a world-leading portfolio in heart recovery – with innovative R&D programs, exclusive FDA approvals, and multiple randomized controlled trials underway with the aim of achieving Class I clinical guidelines for Impella® – to expand access to patient populations.
  • Accelerates near- and long-term sales and earnings growth: The proposed transaction will accelerate pro forma MedTech and Johnson & Johnson enterprise revenue growth. Johnson & Johnson expects the transaction to be slightly dilutive to neutral to adjusted earnings per share in the first year, considering the impact of financing, and then accretive by approximately $0.05 in 2024, and increasingly accretive thereafter.

Transaction Financing and Path to Completion

Under the terms of the agreement, a wholly owned subsidiary of Johnson & Johnson (Merger Sub) will commence a tender offer for all outstanding shares of Abiomed, whereby Abiomed stockholders will be offered an upfront payment of $380.00 per share in cash, along with one non-tradeable CVR that entitles them to up to an additional $35.00 per share in cash if certain clinical and commercial milestones are achieved.

The milestones consist of:

  • $17.50 per share, payable if net sales for Abiomed products exceeds $3.7 billion during Johnson & Johnson's fiscal second quarter of 2027 through fiscal first quarter of 2028, or if this threshold is not met during this period and is subsequently met during any rolling four quarter period up to the end of Johnson & Johnson's fiscal first quarter of 2029, $8.75 per share;
  • $7.50 per share payable upon FDA premarket application approval of the use of Impella® products in STEMI patients without cardiogenic shock by January 1, 2028; and
  • $10.00 per share payable upon the first publication of a Class I recommendation for the use of Impella® products in high risk PCI or STEMI with or without cardiogenic shock within four years from their respective clinical endpoint publication dates, but in all cases no later than December 31, 2029.

Johnson & Johnson expects to fund the transaction through a combination of cash on hand and short-term financing. Johnson & Johnson expects to maintain a strong balance sheet and to continue to support its stated capital allocation priorities of R&D investment, competitive dividends, value-creating acquisitions and strategic share repurchases.

Following the completion of the transaction, Abiomed will operate as a standalone business within Johnson & Johnson MedTech, becoming one of 12 JJMT priority platforms as defined by annual sales of at least $1 billion each. Michael R. Minogue, Abiomed's Chairman, President and Chief Executive Officer has an established succession plan to sustain a strong future and will assist in the transition. Andrew Greenfield, who has 17 years with Abiomed, most recently serving as Chief Commercial Officer has been appointed President of Abiomed. Michael Bodner will lead the integration under Ashley McEvoy's leadership. Michael is a seasoned Interventional Cardiovascular executive with 15+ years in the industry with Johnson & Johnson and Abbott Vascular, most recently serving as Worldwide President of Johnson & Johnson's global leading Biosense Webster Electrophysiology business.

The transaction is expected to be completed prior to the end of the first quarter of 2023 and is conditioned on the tender of a majority of the outstanding shares of Abiomed's common stock, as well as the receipt of applicable regulatory approvals and other customary closing conditions. Assuming the closing of the tender offer, Johnson & Johnson will acquire any shares of Abiomed not tendered into the tender offer through a merger of Merger Sub with and into Abiomed for the same per share consideration as will be payable in the tender offer. The merger will be effected as soon as practicable after the closing of the tender offer.

Advisors

J.P. Morgan Securities LLC is serving as financial advisor to Johnson & Johnson and Cravath, Swaine & Moore LLP is serving as legal advisor.

Goldman Sachs & Co. LLC is serving as financial advisor to Abiomed and Sullivan & Cromwell LLP is serving as legal advisor.

Investor Conference Call

Johnson & Johnson and Abiomed will conduct a conference call with investors to discuss the transaction today, November 1, 2022 at 8:00 a.m. ET.

Participant Dial-In: 877-869-3847 / +1 201-689-8261
Webcast: https://event.webcasts.com/starthere.jsp?ei=1580418&tp_key=06d99df38d

A simultaneous webcast of the call for investors and other interested parties may be accessed by utilizing the link provided above. A replay will be available approximately two hours after the live webcast by visiting www.investor.jnj.com or www.investors.Abiomed.com .

In light of the joint conference call today, Abiomed has cancelled its conference call to discuss its financial results for the second quarter of fiscal year 2023, previously scheduled for 8:00 a.m. ET today.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

About Abiomed

Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com . Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella BTR, STEMI DTU, Automated Impella Controller, Abiomed Breethe OXY-1 System and preCARDIA are pending trademarks of Abiomed, Inc.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding the potential acquisition of ABIOMED. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of ABIOMED or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the risk that the closing conditions for the acquisition will not be satisfied, including the risk that clearance under the Hart-Scott-Rodino Antitrust Improvements Act or other applicable antitrust laws will not be obtained; uncertainty as to the percentage of ABIOMED stockholders that will support the proposed transaction and tender their outstanding shares of common stock of ABIOMED in the Offer; the possibility that the transaction will not be completed in the expected timeframe or at all; potential adverse effects to the businesses of Johnson & Johnson or ABIOMED during the pendency of the transaction, such as employee departures or distraction of management from business operations; the risk of stockholder litigation relating to the transaction, including resulting expense or delay; the potential that the expected benefits and opportunities of the acquisition, if completed, may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care services and products; and trends toward health care cost containment. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the products and employees/operations and clinical work of ABIOMED, as well as the ability to ensure continued performance or market growth of ABIOMED's products. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q, ABIOMED's Annual Report on Form 10-K for the fiscal year ended March 31, 2022, including sections captioned "Special Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in ABIOMED's subsequent Quarterly Reports on Form 10-Q, and other filings by Johnson & Johnson and ABIOMED with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , or, in the case of Johnson & Johnson, at www.jnj.com or on request from Johnson & Johnson, or, in the case of ABIOMED, at www.abiomed.com or on request from ABIOMED. Neither Johnson & Johnson nor ABIOMED undertakes to update any forward-looking statement as a result of new information or future events or developments, except as required by law.

Additional Information

The tender offer described in this communication has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell securities. At the time the tender offer is commenced, Johnson & Johnson will cause Merger Sub to file a tender offer statement on Schedule TO with the U.S. Securities and Exchange Commission (" SEC "). Investors and ABIOMED security holders are strongly advised to read the tender offer statement (including an offer to purchase, letter of transmittal and related tender offer documents) that will be filed by Johnson & Johnson with the SEC and the related solicitation/recommendation statement on Schedule 14D-9 that will be filed by ABIOMED with the SEC, when they become available, because they will contain important information. These documents will be available at no charge on the SEC's website at www.sec.gov . In addition, a copy of the offer to purchase, letter of transmittal and certain other related tender offer documents (once they become available) may be obtained free of charge by directing a request to Johnson & Johnson, Office of the Corporate Secretary, One Johnson & Johnson Plaza, New Brunswick, NJ 08933, Attn: Corporate Secretary's Office. A copy of the solicitation/recommendation statement on Schedule 14D-9 (once it becomes available) also may be obtained free of charge from ABIOMED under the "Investors" section of ABIOMED' website at https://investors.abiomed.com .

Johnson & Johnson:
 
Press Contacts  
Jake Sargent
jsargen3@its.jnj.com

Rachel Hooper
rhooper@its.jnj.com

Investor Contacts  
Jessica Moore
jmoore29@its.jnj.com

Sarah Wood
swood15@its.jnj.com

Abiomed:  
Jenny Leary
jleary@abiomed.com

News Provided by Business Wire via QuoteMedia

JNJ
The Conversation (0)
doctor with hands together, palms up below digital medical symbols

Innovations and Opportunities in European Healthcare Technologies

In recent years, European companies have emerged as trailblazers in healthcare technology, effectively changing the face of health and patient care. Through innovation, they're not only improving systems, processes and patient outcomes but also saving lives.

These advanced European technologies are often only distributed and implemented exclusively within the European Union. The good news is that it doesn't need to stay this way.

Bringing European healthcare technologies to the North American market can potentially improve healthcare in this part of the world, open up new market opportunities for investors and expose those companies to significant growth capital.

Keep reading...Show less
Johnson & Johnson to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference

Johnson & Johnson to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference

Johnson & Johnson (NYSE: JNJ) will participate in the Goldman Sachs 44 th Annual Global Healthcare Conference on Tuesday, June 13 th , at the Waldorf Astoria Monarch Beach Resort & Club in Dana Point, CA. Biljana Naumovic, Worldwide Vice President, Oncology, and Peter Lebowitz, Global Therapeutic Head, Oncology, will represent the Company in a session scheduled at 4:20 p.m. (Eastern Time).

This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Johnson & Johnson and Kenvue Announce Pricing of Upsized Kenvue Inc. Initial Public Offering

Johnson & Johnson and Kenvue Announce Pricing of Upsized Kenvue Inc. Initial Public Offering

Johnson & Johnson (NYSE: JNJ) and Kenvue Inc. ("Kenvue"), a wholly owned subsidiary of Johnson & Johnson, today announced the pricing of Kenvue's upsized initial public offering ("IPO") of 172,812,560 shares of Kenvue's common stock at a price to the public of $22.00 per share. In addition, Kenvue has granted the underwriters a 30-day option to purchase up to an additional 25,921,884 shares of its common stock to cover over-allotments, if any. Kenvue's common stock has been approved for listing on the New York Stock Exchange under the symbol "KVUE" and is expected to begin trading on May 4, 2023. The IPO is expected to close on May 8, 2023, subject to the satisfaction or waiver of customary closing conditions.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Johnson & Johnson to Participate in the Bernstein 39th Annual Strategic Decisions Conference

Johnson & Johnson to Participate in the Bernstein 39th Annual Strategic Decisions Conference

Johnson & Johnson (NYSE: JNJ) will participate in the Bernstein 39 th Annual Strategic Decisions Conference on Wednesday, May 31 st , at the New York Hilton Midtown in New York. Joaquin Duato, Chairman of the Board and Chief Executive Officer will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Kaleido Collaborates with Janssen on Metabolic Therapies

Kaleido Biosciences (NADAQ:KLDO) announced a research collaboration with Janssen’s World Without Disease Accelerator, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ).

As quoted in the press release:

Keep reading...Show less
Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-affera-pulsed-field-ablation-technologies-continue-to-demonstrate-promising-evidence-for-atrial-fibrillation-patients-302439006.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

Keep reading...Show less
Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×