Life Science News

Late-breaking data presented at ESC Congress 2022 and simultaneously published in The New England Journal of Medicine confirms implant procedure safety and defibrillation success

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that its investigational EV ICD™ System a first-of-its-kind defibrillator with the lead placed under the breastbone, outside of the heart and veins achieved a defibrillation success rate of 98.7% and met its safety endpoints in a global clinical trial. Findings from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science today at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine. Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution.

The Medtronic EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA), while avoiding certain risks of traditional, transvenous ICDs because its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach. Placing the lead in this location is designed to help avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion (narrowing, blockage or compression of a vein) and risks for blood infections.

The lead is connected to a device that is implanted below the left armpit (in the left mid-axillary region). Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional ICDs.

"We are very encouraged by the high defibrillation effectiveness and strong safety profile of the EV ICD system seen in the study, as we look to deliver less-invasive treatment options for patients at risk of sudden cardiac arrest," said Ian Crozier, MB, CHB, M.D., Christchurch Hospital, Christchurch, New Zealand , who presented the results at ESC Congress 2022. "These results demonstrate the potential for this novel technology to be used as a safe, successful approach for patients with life-threatening arrhythmias."

Study Results: Effectiveness
In the study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7% (298 of 302 patients), surpassing the prespecified performance goal of 88%. These results reflect a greater defibrillation efficacy for the EV ICD than historical transvenous ICD studies; 1-4 comparable efficacy to the subcutaneous ICD despite EV ICD's smaller device size; 5 and a predicted increase in longevity compared to the subcutaneous ICD. Additionally, all discrete spontaneous arrhythmias were successfully treated (18 of 18, 100%).

Further, the efficacy of ATP – which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – in the EV ICD study was comparable to ATP efficacy in transvenous defibrillators. 6,7 In total, 33 shocks were avoided by having ATP programmed "on."

Study Results: Safety
The study also exceeded its safety endpoint: at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death (compared to the performance goal of 79%; p

At six months, 25 major complications were observed in 23 of 316 patients who underwent an implant attempt (7.3%). Twenty-nine patients experienced inappropriate shocks (9.7%, average 10.6 months follow up), most commonly due to P-wave oversensing, which was more frequent in patients implanted early in the study and less frequent among patients implanted later in the study.

"These pivotal data mark the start of a new era in ICD therapy for patients who are at significant risk of dangerously fast heart rhythms," said Alan Cheng , M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "Today's findings are an important clinical milestone toward our goal of delivering a one-system, one-procedure extravascular ICD solution that prevents sudden cardiac arrest while improving the patient experience with a smaller device and moving the lead out of the veins and placing it under the breastbone. The EV ICD system retains the benefits of a completely extravascular system while providing ATP, pause prevention pacing and low defibrillation energy."

The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients at 46 sites in 17 countries in North America , Europe , the Middle East , Asia , Australia and New Zealand . Medtronic has received FDA approval for a Continued Access Study while the agency reviews the company's EV ICD pre-market application.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 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 all. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn .

1 Leong-Sit P, Gula LJ, Diamantouros P, et al. Effect of defibrillation testing on management during implantable cardioverter-defibrillator implantation. Am Heart J 2006;152:1104-8.

2 Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol 2006;17:140-5.

3 Michowitz Y, Lellouche N, Contractor T, et al. Defibrillation threshold testing fails to show clinical benefit during long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation. Europace 2011;13:683-8.

4 Healey JS, Hohnloser SH, Glikson M, et al. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet 2015;385:785-91.

5 Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 2013;128:944-53.

6 Gasparini M, Lunati MG, Proclemer A, et al. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol 2017;3:1275-82.

7 Moss AJ, Schuger C, Beck CA, et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012;367:2275-83.

Contacts :


Tracy McNulty

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-2492

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-extravascular-icd-meets-global-pivotal-clinical-trials-safety-and-effectiveness-endpoints-301613462.html

SOURCE Medtronic plc

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/August2022/28/c6976.html

News Provided by Canada Newswire via QuoteMedia

MDT
Energy Fuels Announces Q2-2022 Results, Including Continued Robust Balance Sheet and Market-Leading U.S. Uranium & Rare Earth Positions

Energy Fuels Announces Q2-2022 Results, Including Continued Robust Balance Sheet and Market-Leading U.S. Uranium & Rare Earth Positions

Webcast on August 9, 2022

Energy Fuels Inc. (NYSE: UUUU) (TSX: EFR) ("Energy Fuels" or the "Company") today reported its financial results for the quarter ended June 30, 2022 . The Company's quarterly report on Form 10-Q has been filed with the U.S. Securities and Exchange Commission (" SEC ") and may be viewed on the Electronic Document Gathering and Retrieval System (" EDGAR ") at www.sec.govedgar.shtml on the System for Electronic Document Analysis and Retrieval (" SEDAR ") at www.sedar.com and on the Company's website at www.energyfuels.com . Unless noted otherwise, all dollar amounts are in U.S. dollars.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Energy Fuels Announces Q1-2022 Results, Including Continued Robust Balance Sheet, Market-Leading U.S. Uranium Position & Rare Earth Production

Energy Fuels Announces Q1-2022 Results, Including Continued Robust Balance Sheet, Market-Leading U.S. Uranium Position & Rare Earth Production

Webcast on May 18, 2022

Energy Fuels Inc. (NYSE: UUUU) (TSX: EFR) ("Energy Fuels" or the "Company") today reported its financial results for the quarter ended March 31, 2022 . The Company's annual report on Form 10-K has been filed with the U.S. Securities and Exchange Commission (" SEC ") and may be viewed on the Electronic Document Gathering and Retrieval System (" EDGAR ") at www.sec.govedgar.shtml on the System for Electronic Document Analysis and Retrieval (" SEDAR ") at www.sedar.com and on the Company's website at www.energyfuels.com . Unless noted otherwise, all dollar amounts are in U.S. dollars.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Energy Fuels Announces 2021 Results, Including Net Profits, Strong Cash Position, and Market-Leading U.S. Uranium, Rare Earth and Vanadium Position

Energy Fuels Announces 2021 Results, Including Net Profits, Strong Cash Position, and Market-Leading U.S. Uranium, Rare Earth and Vanadium Position

Webcast on March 17, 2022

Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) ("Energy Fuels" or the "Company") today reported its financial results for the year ended December 31, 2021 . The Company's annual report on Form 10-K has been filed with the U.S. Securities and Exchange Commission (" SEC ") and may be viewed on the Electronic Document Gathering and Retrieval System (" EDGAR ") at www.sec.govedgar.shtml on the System for Electronic Document Analysis and Retrieval (" SEDAR ") at www.sedar.com and on the Company's website at www.energyfuels.com . Unless noted otherwise, all dollar amounts are in U.S. dollars.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Cloud DX's Post-Surgical Monitoring Wearable Validated in Peer-Reviewed Study

Cloud DX's Post-Surgical Monitoring Wearable Validated in Peer-Reviewed Study

Cloud DX's Post-Surgical Monitoring Wearable Validated in Peer-reviewed Study For the ~800,000 1 Canadian surgery patients per year, continuous monitoring with Vitaliti™ could enable earlier intervention in cases of patient decline.

  • Validation of Cloud DX's Vitaliti™ continuous monitoring device clears way for regulatory approval starting in 2022.
  • Accurate continuous data collection supports earlier detection of changes in patient condition, enabling rapid interventions to improve patient outcomes.
  • Clear opportunity to impact up to ~800,000 1 surgical patients per year in Canada, deliverable through recent partnership with medical technology leader Medtronic.

Cloud DX (TSXV:CDX)(OTCQB:CDXFF), Leading Virtual Care Platform Cloud DX has announced publication of an independent peer-reviewed validation study of its unique Vitaliti™ product, a non-invasive wearable devices that provides continuous vital sign monitoring (CVSM) device. The study assessed regulatory compliance and post-surgery use in monitoring patients' vital signs in real-world conditions. The study found Vitaliti™ to be fully ISO 81060-2:2018 compliant for the continuous vital measurement, clearing the way for regulatory approval starting in 2022. The study also found that patients welcomed the comfortable, easy to use device. Instead of care teams taking vitals periodically after surgery, Cloud DX's Vitaliti™ was used for continuous monitoring, which could transform post-surgical care by enabling early detection if any deterioration occurs in patient health. On launch, Vitaliti™ will become a key component of Cloud DX's Connected Health™ ecosystem of remote monitoring technologies. Through Cloud DX's recent partnership with Medtronic Canada ULC (a subsidiary of Medtronic plc (MDT), a global leader in healthcare technology), wide deployment of Vitaliti™ is intended to initially improve post-operative care for surgical patients in Canada (up to 800,000 annually) and eventually in the United States (up to several million annually

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
InvestmentPitch Media Video Discusses Cloud DX's Selection by Medtronic for Canada-Wide Remote Patient Monitoring - Video Available on Investmentpitch.com

InvestmentPitch Media Video Discusses Cloud DX's Selection by Medtronic for Canada-Wide Remote Patient Monitoring - Video Available on Investmentpitch.com

Cloud DX Inc. (TSXV: CDX) (OTCQB: CDXFF) has been selected by Medtronic Canada ULC, to provide world-class virtual healthcare to Medtronic's patients across Canada. Medtronic Canada, (www.medtronic.ca) headquartered in Brampton, Ontario, with regional offices in Montreal and Vancouver, is the largest medical technology company in Canada, and a subsidiary of Medtronic plc (NYSE: MDT), a multi billion-dollar, global leader in medical technology, offering medical devices and therapies to more than 72 million people across 150 countries.

For more information, please view the InvestmentPitch Media "video" which provides additional information about this news and the company, along with comments from Robert Kaul, CEO of Cloud DX, about the significance of this news. If this link is not enabled, please visit www.InvestmentPitch.com and enter "Cloud DX" in the search box.

This partnership advances Medtronic's commitment to improving patient outcomes and lowering overall costs along the care continuum. Medtronic Canada delivers care in a broad range of clinical areas, including spinal and cardiac surgeries, cardiology, critical care, diabetes, vascular and renal care. Most clinical areas are expected to improve patient outcomes and satisfaction with some aspect of virtual care in the future.

Cloud DX's Connected Health™ remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Its partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources.

Cloud DX's remote patient monitoring technology and services are exclusive to Medtronic and its Canada-wide client base. Initially, Medtronic seeks to integrate the Connected Health™ platform and associated services within both perioperative and complex chronic disease pathways in Canada.

Under the agreement, a typical deployment would involve the enrollment of a chronic care or surgical patient onto the Connected Health™ platform, generating recurring revenue, depending on the length of the monitoring program. Cloud DX generates revenue upfront for kits prescribed to patients for use at home, and then a monthly subscription fee per patient for software, services, and support. Additional revenues could also be generated through customizations, consulting, and special services, as needed.

Jessica Rudd, National Director of New Partnerships and Solutions at Medtronic Canada, stated: "Medtronic is committed to partnering with Canada-based SMEs to advance the Canadian life sciences ecosystem. More importantly, Medtronic Canada is dedicated to responding to the needs of our Canadian healthcare system, and we are committed to enabling equitable access to care and patient empowerment and reducing the burden on our precious health human resources. However, we can't do this alone. To that end, we are delighted to enter this exclusive partnership with Cloud DX and scale their innovative technology, thoughtful service model, and excellent track record for delivering results to patients across the country."

Among its many awards, Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of " Canada's Ten Most Prominent Telehealth Providers.

The shares are trading at $0.195. For more information, please visit the company's corporate website www.CloudDX.com, and the company's investor relation site ir.CloudDX.com/overview/default.aspx, contact Jay Bedard, Investor Relations, at 647-881-8418 or by email at jay.bedard@CloudDX.com.

About InvestmentPitch Media

Investmentpitch Media leverages the power of video, which together with its extensive distribution, positions a company's story ahead of the 1,000's of companies seeking awareness and funding from the financial community. The company specializes in producing short videos based on significant news releases, research reports and other content of interest to investors.

CONTACT:
InvestmentPitch Media
Barry Morgan, CFO
bmorgan@investmentpitch.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/106272

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Knight Therapeutics Inc. places No. 22 on The Globe and Mail's fourth-annual ranking of Canada's Top Growing Companies

Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") is pleased to announce it placed No. 22 on the 2022 Report on Business ranking of Canada's Top Growing Companies.

Canada's Top Growing Companies ranks Canadian companies on three-year revenue growth. Knight earned its spot with three-year growth of 1,850%.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Bausch Health and Glenmark Announce the approval of RYALTRIS® in Canada

- RYALTRIS ® (olopatadine hydrochloride and mometasone furoate nasal spray) treats moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older

Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) ("Bausch Health") and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), are pleased to announce that RYALTRIS ® (olopatadine hydrochloride and mometasone furoate nasal spray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older. 1

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
person using high-tech ipad

Health is Wealth: The Point-of-Care Health Technology Model

To say the past few years have been a transformative time for healthcare would be putting it lightly.

Care providers all over the world continue to embrace the healthcare industry-wide digital transformation. We’ve seen the rise of transformative new technologies and the creation of new care models — all with one goal in mind: promoting and achieving better patient outcomes. Add to that the evolving role of pharmacies as a critical location for deploying point-of-care testing, and it’s clear why this innovative model is rapidly catching on.

Already a US$1.7 trillion business globally, the pharmacy sector is transitioning from a dispensation model of care to a more profitable, successful, patient-focused services model — supporting the growth of point-of-care technology in the process.

Keep reading...Show less

Medtronic announces closing of public offering of Euro3.5 billion of senior notes

Medtronic plc (the "Company") (NYSE: MDT) today announced that its wholly-owned subsidiary Medtronic Global Holdings S.C.A. ( "Medtronic Luxco") has closed a registered public offering (the "Offering") of €500,000,000 principal amount of 2.625% Senior Notes due 2025, €1,000,000,000 principal amount of 3.000% Senior Notes due 2028, €1,000,000,000 principal amount of 3.125% Senior Notes due 2031 and €1,000,000,000 principal amount of 3.375% Senior Notes due 2034 (collectively, the "Notes"). All of Medtronic Luxco's obligations under the Notes are fully and unconditionally guaranteed by the Company and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

The net proceeds from the Offering are approximately €3.47 billion, after deducting underwriting discounts and commissions and estimated expenses related to the Offering payable by Medtronic Luxco. The net proceeds of the Offering are expected to be used to repay at maturity Medtronic Luxco's outstanding 0.00% Senior Notes due 2022, 0.375% Senior Notes due 2023 and 0.00% Senior Notes due 2023 and for general corporate purposes. While Medtronic Luxco may elect at a later date to repay, redeem or repurchase such notes prior to maturity, it currently has no intention to repay, redeem or repurchase such notes prior to maturity.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Danaher Schedules Third Quarter 2022 Earnings Conference Call

Danaher Corporation (NYSE: DHR) announced that it will webcast its quarterly earnings conference call for the third quarter 2022 on Thursday, October 20, 2022 beginning at 8:00 a.m. ET and lasting approximately 1 hour.

The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher's website, www.danaher.com , under the subheading "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic receives FDA clearance for expanded indication of LINQ II insertable cardiac monitor for use in pediatric patients ages 2 and older

The LINQ II ICM is the first continuous, long-term cardiac monitor cleared by FDA for the pediatric patient population

- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the LINQ II™ Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×