Abbott Receives CE Mark for Navitor, the Latest-Generation Transcatheter Aortic Valve Implantation System to Treat Aortic Stenosis

Abbott (NYSE: ABT) today announced it has received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor™, making the minimally invasive device available for people in Europe with severe aortic stenosis who are at high or extreme surgical risk. With the Navitor valve, the company is advancing TAVI (also referred to as TAVR, or transcatheter aortic valve replacement) therapies with innovations including a unique design to prevent blood leaking around the valve. Using Abbott's industry-leading FlexNav™ delivery system, the Navitor TAVI system is the latest addition to the company's comprehensive structural heart transcatheter portfolio that offers physicians and patients less invasive options to treat heart diseases.

Aortic stenosis restricts blood flow through the aortic heart valve to the rest of the body, which can lead to heart failure and, in certain cases, sudden cardiac death. 1 For some people diagnosed with severe aortic stenosis, open-heart surgery is considered a high-risk procedure due to the potential complications stemming from age, frailty or having multiple other diseases or conditions. 2 TAVI serves as a less invasive alternative to surgical aortic valve replacement and can reduce symptoms and improve the lives of patients with this debilitating condition.

"With an aging world population and with aortic stenosis cases projected to double in Europe and the U.S. in the next few decades, the need for innovative, minimally invasive solutions is critical," said Lars Søndergaard, M.D., professor of Cardiology, Rigshospitalet, Copenhagen University Hospital in Denmark , who served as co-principal investigator for the global Navitor TAVI system clinical study. "While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVI systems when we encounter complex patient anatomies that can lead to potential complications."

Navitor features a unique fabric cuff (NaviSeal™) that works with the cardiac cycle to reduce or eliminate a backflow of blood around the valve frame known as paravalvular leak (PVL), a common complication following TAVI procedures. The new device is the only self-expanding TAVI system with intra-annular (within the native valve) leaflets and large frame cells – features designed to help improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease (CAD). The new design additionally provides improved hemodynamics, or better blood flow.

The Navitor device is implanted with Abbott's FlexNav delivery system, which received CE Mark in 2020 and offers a slim design with the lowest TAVI delivery system profile, allowing treatment of people with vessels as small as 5.0 mm. The slim catheter can accommodate different aortic anatomies for stable, predictable and accurate valve delivery and placement.

"The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives," said Michael Dale, senior vice president of Abbott's structural heart business. "This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition."

For more information on Navitor, please visit: https://www.navitorvalve.com .

The Navitor Transcatheter Aortic Valve and FlexNav Delivery System are approved for investigational use only in the U.S.

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 109,000 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 .

1 Mayo Clinic. Transcatheter aortic valve replacement (TAVR). August 2020 .
2 Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD Jr, Gualano SK. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009. November; 2 6: 533– 9.

Cision View original content: https://www.prnewswire.com/news-releases/abbott-receives-ce-mark-for-navitor-the-latest-generation-transcatheter-aortic-valve-implantation-tavi-system-to-treat-aortic-stenosis-301292141.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Bausch Health Responds to Rumors of a Potential Sale of Bausch + Lomb

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, issued the following statement in response to a request from the Canadian Investment Regulatory Organization (CIRO

"As previously disclosed, the Company believes that completing the full separation of its subsidiary, Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), makes strategic sense. The Bausch Health Board of Directors authorized management and management of its subsidiary, Bausch + Lomb, to explore a potential sale, which is one of several options being considered to complete the separation. That process is ongoing. No decision has been reached to proceed with any particular transaction, and there can be no assurance that it will result in a transaction.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Medtronic announces cash dividend for third quarter of fiscal year 2025

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, December 5, 2024, approved the company's cash dividend for the third quarter of fiscal year 2025 of $0 .70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on January 10, 2025 to shareholders of record at the close of business on December 27, 2024 .

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 , visit www.Medtronic.com and follow Medtronic on LinkedIn .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Limited (ASX:CDX)

Cardiex Limited


Keep reading...Show less

Bausch Health and Salix in Collaboration with Health Organizations Recognize the Second Annual Opioid-Induced Constipation Awareness Day

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), alongside the U.S. Pain Foundation (USPF), the International Foundation for Gastrointestinal Disorders (IFFGD), and the American Chronic Pain Association (ACPA) have united to recognize today, Thursday, December 5, as the second annual Opioid-Induced Constipation (OIC) Awareness Day. This important day is dedicated to bringing awareness to a commonly-overlooked side effect of opioids. By raising awareness and fostering open conversations, OIC Awareness Day seeks to reduce the stigma surrounding this condition and offer support to the many patients impacted by OIC

"As an organization dedicated to supporting individuals living with pain conditions, we're proud to participate in this year's OIC Awareness Day," said Kathy Sapp, CEO of ACPA. "By increasing awareness and improving communication between healthcare providers, patients, and caregivers, we can make a meaningful difference for those affected by this commonly occurring condition."

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Global Medical Service Robotics Market Project to Exceed $20 Billion in 2024 with Additional Growth Expected

FN Media Group News Commentary - Innovations in robotics technology, including artificial intelligence machine learning, and sensor technology, are enhancing the capabilities of medical robots. These advancements enable more precise surgical procedures, improved rehabilitation processes, and efficient hospital logistics, thus attracting more healthcare facilities to adopt robotic solutions. The market is characterized by a moderate level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to expand the business to cater to the growing demand for medical service robots. A report from Grand View Research said that the global medical service robots market size was estimated at USD 20.59 billion in 2024 and is projected to grow at a CAGR of 16.5% from 2025 to 2030. It said: "The growth can be attributed to the introduction of technologically advanced robotic equipment in the healthcare sector and the rise in per capita healthcare spending. Continuous advancements in technology, such as robotic catheter control systems (CCS), data recorders, data analytics, remote navigation, motion sensors, 3D-Imaging, and HD surgical microscopic cameras, are projected to drive industry growth. Furthermore, the introduction of swarm robotics is opening new opportunities for industry. It is a new approach to coordinating multi-robotic systems through swarm intelligence." Active Tech Companies in the markets today include Jeffs' Brands Ltd (NASDAQ: JFBR), Serve Robotics Inc. (NASDAQ: SERV), Symbotic Inc. (NASDAQ: SYM), Microbot Medical Inc. (NASDAQ: MBOT), Medtronic plc (NYSE: MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×