Technology | Heart Valve Technology | September 24, 2019

Medtronic Launches Evolut Pro+ TAVR System

Next-generation transcatheter aortic valve replacement (TAVR) system offers improved functionality across four valve sizes and lowest delivery profile on the market, according to Medtronic

Medtronic Launches Evolut Pro+ TAVR System

September 24, 2019 – Medtronic announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut Pro+ transcatheter aortic valve replacement (TAVR) system. The new-generation Medtronic TAVR system builds off the self-expanding, supra-annular Evolut TAVR platform. The Evolut Pro+ TAVR System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market, according to Medtronic. The launch comes on the heels of the FDA’s recent indication expansion for the Evolut TAVR platform to treat patients with symptomatic severe aortic stenosis at a low risk of surgical mortality, the final surgical risk category to be approved for TAVR.

Read the article "FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology"

“As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it’s critically important to have valve technology available that keeps pace with the evolution of the therapy,” said Mathew R. Williams, M.D., director of the Heart Valve Program at the NYU Langone Health in New York City. ”Valve technologies that are designed to help minimize paravalvular leak, simplify the valve delivery during the procedure, and for unobstructed blood flow are factors that have made TAVR an excellent choice for many patients.”

The Evolut Pro+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market according to Medtronic (the 23-, 26- and 29-mm valves can treat vessels down to 5 mm). It features four valve sizes – including the 34 mm (treats vessels down to 6 mm) – with an external tissue wrap and an integrated, inline sheath, allowing physicians to treat patients with a range of anatomical variations. Consistent with the Evolut platform design, the Pro+ valve is designed with a self-expanding nitinol frame that conforms to the native annulus with consistent radial force and advanced sealing. The valve incorporates an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus to help potentially reduce incidences of paravalvular leaks.

“Physicians are treating a broader range of patient anatomies than ever before – from large to small, from simple to complex,“ said Guilherme Attizzani, M.D., interventional cardiologist and director Valve and Structural Heart Disease Center at University Hospitals in Cleveland. ”Adding the external tissue wrap to the large 34mm valve size, which wasn’t previously available, is a major technological improvement that will benefit many patients with larger anatomies.”

Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and, therefore, impacting an individual’s daily activities. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.

The Evolut TAVR platform, including the Evolut R, Evolut Pro and Evolut Pro+ systems, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S.

For more information: www.medtronic.com

Related TAVR Content

National Coverage Determination Will Make TAVR Available to More Patients at More Centers

VIDEO: TAVR Stands Equal to Surgical Valve Replacement — Interview with Michael Reardon, M.D.

Study Finds TAVR Can Be Considered for Patients in All Surgical Risk Classes

VIDEO: Edwards Lifesciences Sapien 3 TAVR Procedural Animation

TAVR Performs Well Compared to Surgical Aortic Valve Replacement in Low Risk Patients

CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement

TAVR Outperforms Surgery in Younger, Low-Risk Aortic Stenosis Patients

VIDEO: Tracking Transcatheter Valve Outcomes in the STS-ACC TVT Registry — interview with John Carroll, M.D.

Interventional Imagers: The Conductors of the Heart Team Orchestra

Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System

Length of Stay Impacts TAVR Outcomes

VIDEO: TAVR For Asymptomatic Severe Aortic Stenosis — Interview with  Philippe Genereux, M.D.

How to Perform Transcaval TAVR Access

The Essentials of Structural Heart Imaging

Hospital Consolidation May Increase Access to TAVR, New Cardiac Technologies

VIDEO: Outcomes Following Urgent TAVR - Results from the TVT Registry — Interview with Sammy Elmariah, M.D.

Valve Replacement Volume Key to Successful Patient Outcomes

TAVR Operator and Hospital Requirements Outlined in 2018 AATS/ACC/SCAI/STS Expert Consensus

VIDEO: Overview of University of Colorado Structural Heart Program

VIDEO: TAVR for Degenerated Surgical Valves, Valve-in-Valve TAVR Procedures — Interview with Sammy Elmariah, M.D.

VIDEO: Advice For Hospitals Starting a Structural Heart Program — interview with John Carroll, M.D.

VIDEO: How to Get Referral Patients Into a Structural Heart Program

Recent Advances in Transcatheter Valve Technology


Related Content

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now