Tele: 561.316.3330
Breaking Medical Device News

Monday, September 20, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeMEDTRONIC plcMedtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing

Medtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing

Medtronic plc announced today the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM) Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open-heart surgery.

The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.

The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.

“Based on my experience implanting the Evolut PRO valve during the clinical study, I’ve been impressed by the clinical outcomes achieved in our patients,” said Mathew Williams, M.D., chief of Adult Cardiac Surgery and director of Interventional Cardiology and the Heart Valve Program at the NYU Langone Medical Center in New York City. “This innovation represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases.”

The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) experienced no/trace PVL and no incidents of severe PVL were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10 percent.

“The 30-day clinical outcomes presented at ACC demonstrate the Evolut PRO valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery,” said John Forrest, M.D., assistant professor of medicine at Yale University School of Medicine in New Haven, Conn., who presented the data at the meeting.

Built on the proven platform of the recapturable CoreValve Evolut R System, the Evolut PRO valve includes a self-expanding nitinol frame with its supra-annular valve position that helps achieve excellent hemodynamic performance.

“Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic,” said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic’s Cardiac and Vascular Group. “We are excited to introduce the next evolution of our Evolut TAVR platform to provide physicians with a comprehensive portfolio to address their patients’ needs.”

The Evolut PRO System is delivered through the EnVeo(TM) R Delivery Catheter System and is indicated for vessels down to 5.5 mm. The EnVeo R system features an InLine Sheath that makes it the lowest delivery platform currently on the market. It also provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route.

The 23 mm, 26 mm and 29 mm sizes of the Evolut PRO System are available for use in the United States. It is not available for use in countries outside of the United States.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

By using this website you agree to accept Medical Device News Magazine Privacy Policy