Life Science News

Abbott Receives FDA Approval for Navitor, a Next-Generation TAVI System Designed to Treat Aortic Stenosis

  • Abbott's new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood leakage around valve implant
  • Transcatheter aortic valve implantation (TAVI) offers minimally invasive alternative to surgery for people with aortic stenosis, a common and life-threatening heart valve disease

Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor™, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The Navitor TAVI system is the latest addition to the company's comprehensive transcatheter structural heart portfolio that offers less invasive treatment options to physicians and patients for some of the most common and serious heart diseases.

Aortic stenosis occurs when the aortic valve's opening narrows, restricting blood flow to the body. Left untreated, it can lead to heart failure and death. For patients with severe aortic stenosis who are at high or extreme surgical risk due to the potential complications stemming from age, frailty, or having multiple other diseases or conditions, physicians may opt for a minimally invasive procedure using TAVI therapies such as the Navitor system.

"Abbott's Navitor device features advancements to help doctors safely and effectively treat patients with aortic stenosis, including a design that reduces the backflow of blood around the valve that's often a complication following TAVI procedures," said Michael Reardon , M.D., Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, who served as principal investigator for the study that led to FDA approval. "The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies."

Navitor features a unique fabric cuff (NaviSeal™) to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak (PVL). Additionally, the new device is the only self-expanding TAVI system with leaflets within the native valve; this design can help improve access to coronary arteries to facilitate future procedures for treating coronary artery disease. The system provides excellent hemodynamics, or blood flow, through the valve. The Navitor device is implanted using Abbott's FlexNav™ delivery system, which features a slim design to accommodate different patient anatomies and small vessels for stable, predictable and accurate valve delivery and placement.

"Our Navitor valve builds upon our industry-leading portfolio of minimally invasive devices that surpass existing standards of care to address a range of heart diseases," said Michael Dale, senior vice president of Abbott's structural heart business. "Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution. Receiving this approval is a major next step in our mission to help people live better lives through better health."

For U.S. important safety information on Navitor, visit https://abbo.tt/NavitorISI .

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

Cision View original content: https://www.prnewswire.com/news-releases/abbott-receives-fda-approval-for-navitor-a-next-generation-tavi-system-designed-to-treat-aortic-stenosis-301722683.html

SOURCE Abbott

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Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

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Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 “long haulers,” who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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abt stock

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 "long haulers," who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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Aehr Test Systems Receives Orders of Over $2.3 million

Aehr Test Systems (NASDAQ:AEHR) has over 2,500 systems installed over the world that test optical and memory integrated circuits, semiconductors and reliability qualification equipment announced that it received over $2.3 million in orders for test and burn-in services. These orders came from a major manufacturer where Aehr’s services would be implemented for automotive products.

As quoted in the press release:

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Cyclacel Reports Fourth Quarter And 2016 Financial Results

Cyclacel Pharmaceuticals (NASDAQ:CYCC) posted its financial results for the fourth quarter and full year 2016.
As quoted in the press release:

The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

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Federal Appellate Court Rejects Controversial J&J Ploy to Dodge Talc Cancer Lawsuits

Nachawati Law Group: Ovarian cancer victims deserve day in court

Trial lawyers with the Nachawati Law Group praised a ruling by the U.S. Court of Appeals for the Third Circuit rejecting Johnson & Johnson's (NYSE: JNJ) use of a controversial bankruptcy ploy to shed more than 38,000 lawsuits filed by women who developed ovarian cancer after using J&J's talc-based products.

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FDA Approves Abbott's Spinal Cord Stimulation for People Living with Painful Diabetic Peripheral Neuropathy

  • The new indication for Abbott's Proclaim™ XR SCS system provides a non-medication option for people with painful diabetic peripheral neuropathy
  • Spinal cord stimulation is proven to be more effective than conventional medical management in the treatment of chronic pain 1,2

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim™ XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott's NeuroSphere™ Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.

Roughly 34.2 million Americans, or 10.5% of the U.S. population, have diabetes. 3 Diabetic neuropathy, one of the complications of diabetes, is a type of damage seen predominately in nerves running to the feet. 4 During their lifetime, approximately 50% of adults with diabetes will develop peripheral neuropathy, which may include symptoms such as pain and numbness in the legs, feet and hands. 5

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Medtronic recommends rejection of below-market mini-tender offer by TRC Capital Investment Corporation

Medtronic plc (NYSE:MDT) recently became aware that TRC Capital Investment Corporation (TRC) has made an unsolicited mini-tender offer to purchase up to 1,500,000 Medtronic ordinary shares, representing approximately 0.1% of the company's outstanding ordinary shares. TRC's offer price of $77.25 per share in cash is approximately 4.5% lower than the $80.91 closing price of Medtronic ordinary shares on January 20, 2023 the last closing price prior to commencement of the offer.

Medtronic does not recommend or endorse TRC's unsolicited below-market mini-tender offer. Further, because the offer is at a price significantly below the current market price of Medtronic ordinary shares, Medtronic recommends that shareholders not tender their shares. Medtronic is not affiliated or associated with TRC, its mini-tender offer, or the mini-tender offer documentation.

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Abbott Reports Fourth-Quarter and Full-Year 2022 Results; Issues 2023 Financial Outlook

  • Fourth-quarter sales of $10.1 billion ; full-year 2022 sales of $43.7 billion
  • Full-year 2022 sales growth of 1.3 percent; organic sales growth of 6.4 percent
  • Full-year 2022 GAAP diluted EPS of $3.91 ; adjusted diluted EPS of $5.34
  • Continues to strengthen portfolio with steady cadence of new product approvals

Abbott (NYSE: ABT) today announced financial results for the fourth quarter ended Dec. 31, 2022 .

  • Fourth-quarter sales of $10.1 billion , which were negatively impacted by an expected year-over-year decline in COVID-19 testing-related sales, decreased 12.0 percent on a reported basis and 6.1 percent on an organic basis, which excludes the impact of foreign exchange.
  • Excluding COVID-19 testing-related sales 1 , fourth-quarter sales decreased 1.4 percent on a reported basis and increased 5.4 percent on an organic basis.
  • Excluding COVID-19 testing-related sales 2 and U.S. infant formula sales that were impacted by manufacturing disruptions 3 , full-year 2022 sales increased 1.9 percent on a reported basis and 7.4 percent on an organic basis.
  • GAAP diluted EPS was $0.59 in the fourth quarter. Excluding specified items, adjusted diluted EPS was $1.03 .
  • Abbott issues full-year 2023 guidance for diluted EPS from continuing operations on a GAAP basis of $3.05 to $3.25 and full-year adjusted EPS from continuing operations of $4.30 to $4.50 .
  • Abbott projects full-year 2023 organic sales growth, excluding COVID-19 testing-related sales, of high-single digits 4 and COVID-19 testing-related sales of around $2.0 billion .
  • In October, Abbott's market-leading FreeStyle Libre ® continuous glucose monitoring system was named the "Best Medical Technology" of the last 50 years by the Galien Foundation.
  • In December, Abbott announced U.S. Food and Drug Administration (FDA) approval of its Eterna™ spinal cord stimulation system — the smallest implantable, rechargeable system currently available for the treatment of chronic pain. 5
  • In January, Abbott announced U.S. FDA approval of its minimally invasive Navitor™ transcatheter aortic valve implantation (TAVI) system for people with severe aortic stenosis who are at high risk for surgery.

"We significantly exceeded the EPS guidance we provided at the beginning of last year despite challenging global business conditions," said Robert B. Ford , chairman and chief executive officer, Abbott. "Our R&D pipeline continues to be highly productive with several recent and upcoming new product launches that position us well going forward."

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Singular Health Group Limited

Completion of Global3D Acquisition

Medical technology company Singular Health Group Ltd (ASX: SHG) (“Singular Health”, or “the Company”) is pleased to advise that it has completed the acquisition of the assets of Global3D Pty Ltd (“Global3D”) as previously announced on 6 December 2022. The acquisition is the culmination of over two years of working together with Global3D to investigate and develop enhanced software, technology and 3D printing processes for a range of medical devices, including customised ankle foot orthotics and individualised prosthetics.

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Johnson & Johnson Reports Q4 and Full-Year 2022 Results

  • 2022 Fourth-Quarter reported sales decline of 4.4% to $23.7 Billion primarily driven by unfavorable foreign exchange and reduced COVID-19 Vaccine sales vs. prior year. Operational growth excluding COVID-19 Vaccine of 4.6%*
  • 2022 Fourth-Quarter earnings per share (EPS) of $1.33 decreasing 24.9% and adjusted EPS of $2.35 increasing by 10.3%*
  • 2022 Full-Year reported sales growth of 1.3% to $94.9 Billion primarily driven by strong commercial execution partially offset by unfavorable foreign exchange. Operational growth of 6.1%*
  • 2022 Full-Year earnings per share (EPS) of $6.73 decreasing 13.8% and adjusted EPS of $10.15 increasing by 3.6%*
  • Company guides 2023 adjusted operational sales growth excluding COVID-19 Vaccine of 4.0%* and adjusted operational EPS of $10.50, reflecting growth of 3.5%*

Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2022. "Our full year 2022 results reflect the continued strength and stability of our three business segments, despite macroeconomic challenges," said Joaquin Duato, Chairman of the Board and Chief Executive Officer. "I am inspired by our employees who make a difference in the health and lives of people around the world every day. As we look ahead to 2023, Johnson & Johnson is well-positioned to drive near-term growth, while also investing strategically to deliver long-term value."

OVERALL FINANCIAL RESULTS