News | May 17, 2007

First Cath Lab-Based Device for Aortic Valve Replacement Approved in Europe

May 18, 2007 — CoreValve has announced that it has received CE Mark approval of its CoreValve Percutaneous ReValving System for treatment of high-risk patients.

The patented system consists of a novel porcine pericardial tissue valve mounted in a self-expanding multilevel frame, which is permanently implanted over the diseased aortic heart valve by an 18-French-sized catheter. The small size of the delivery catheter is a key element of the system as it greatly improves overall maneuverability and valve placement while also eliminating the need for surgical cut-down of the femoral artery.

CoreValve also announced that it will not immediately market the ReValving System. The company will instead proceed with an expanded clinical evaluation at a small number of select international centers to help ensure that interventional cardiologists are well trained, that patients are appropriately selected for treatment, and that appropriate clinical feedback is obtained. CoreValve has established a mandatory expanded clinical evaluation patient registry to gather additional clinical data for submission to the FDA in support of clinical trials and regulatory approval in the USA.

For more information visit www.corevalve.com


Related Content

News | Heart Valve Technology

June 27, 2025 – Foldax Inc., a leader in the development of innovative polymer heart valves, has announced compelling ...

Home June 27, 2025
Home
News | Heart Valve Technology

June 04, 2025 — HeartSciences Inc. has announced that the U.S. Food and Drug Administration has granted Breakthrough ...

Home June 12, 2025
Home
News | Heart Valve Technology

May 27, 2025 — Abbott has announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne ...

Home May 28, 2025
Home
News | Heart Valve Technology

May 2, 2025 – New analysis from the EARLY TAVR trial showed patients between the age of 65 and 70 years old derived the ...

Home May 02, 2025
Home
News | Heart Valve Technology

April 28, 2025 — The Society of Thoracic Surgeons (STS) has launched its latest surgical risk calculator designed for ...

Home April 29, 2025
Home
News | Heart Valve Technology

March 30, 2025 — Medtronic has announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data ...

Home March 31, 2025
Home
News | Heart Valve Technology

Feb. 22, 2025 — More than 60,000 people die from heart valve disease (HVD) in the U.S. each year, according to the ...

Home March 04, 2025
Home
News | Heart Valve Technology

Feb. 17, 2025 — The International Consortium for Health Outcomes Measurement (ICHOM) has developed a globally inclusive ...

Home February 18, 2025
Home
News | Heart Valve Technology

Feb. 13, 2025 — Research from Cedars-Sinai investigators and collaborators at other leading medical institutions is ...

Home February 18, 2025
Home
News | Heart Valve Technology

Jan. 25, 2025—A new study presented at the 2025 Society of Thoracic Surgeons (STS) Annual Meeting reveals that ...

Home January 27, 2025
Home
Subscribe Now