News | Structural Heart | May 29, 2020

Neovasc Files CE Mark for Tiara TA Transapical Mitral Valve Replacement System

Neovasc Files CE Mark for Tiara TA Transapical Mitral Valve Replacement System

Neovasc Files CE Mark for Tiara TA Transapical Mitral Valve Replacement System. TMVR

May 29, 2020 — Neovasc Inc., developer of a minimally invasive transcatheter mitral valve replacement (TMVR) technologies, announced that the company has filed for European CE mark for its Tiara TA Transapical mitral valve replacement system.

Mitral valve disease is one of the most common forms of heart disease that affects millions of patients worldwide. Traditional heart valve replacement surgery requires patients to be placed on a heart-lung bypass machine and results in lengthy recovery time. The Tiara TA transapical mitral valve replacement system uses a percutaneous or “key-hole” incision in the chest to completely replace the native mitral valve and avoids the need for heart-lung bypass. The less invasive approach may allow for more patients to be treated and more rapid recovery.

In April, the European Parliament voted overwhelmingly to extend the Medical Device Directive (MDD) by one year rather than to transition to a new approval process known and the European Medical Device Regulation (MDR). 

“Yesterday we received confirmation from our Notified Body in Europe that the ongoing review of our Tiara application will continue under the MDD regulation.  Now that we have clarity on the regulatory approach, a well-defined pathway, we look forward to continued collaboration with the European authorities,” said Fred Colen, Neovasc CEO.

Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients affected throughout Europe. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.

The Tiara valve is not commercially available and is currently being evaluated in two ongoing clinical trials: TIARA-I, an early feasibility trial in the United States, Canada, and Belgium; and TIARA-II, a European Conformité Européenne Mark Trial in Germany, Italy, Spain, and the United Kingdom. In addition, patients have also been treated under compassionate programs in Canada, Italy, Germany, Israel and Switzerland.

For more information: www.neovasc.com
 


Related Content

News | Structural Heart

On July 16, Diagnostic and Interventional Cardiology will present a webinar on "Maximizing Structural Heart Workflows ...

Home July 08, 2024
Home
News | Structural Heart

July 3, 2024 — Jon Kobashigawa, MD, director of the Heart Transplant Program in the Department of Cardiology in the ...

Home July 03, 2024
Home
News | Structural Heart

June 7, 2024 — Medtronic today announced new data from the CoreValve Evolut Clinical Program, reinforcing the positive ...

Home June 07, 2024
Home
News | Structural Heart

April 25, 2024 — Atlantic Health System’s Morristown Medical Center treated the first patient in New Jersey using ...

Home April 25, 2024
Home
News | Structural Heart

April 9, 2024 — UC Davis Health cardiology team members are among the first in the country to treat patients with ...

Home April 09, 2024
Home
News | Structural Heart

March 25, 2024 — In a groundbreaking medical advancement, three esteemed cardiologists from CLS Health, Dr. Bahaeddin ...

Home March 25, 2024
Home
News | Structural Heart

March 12, 2024 — Medtronic plc, a global leader in healthcare technology, today announced two late-breaking data ...

Home March 12, 2024
Home
News | Structural Heart

February 20, 2024 — As New Jersey’s leading provider of high-quality cardiac procedures and diagnostic testing and an ...

Home February 20, 2024
Home
News | Structural Heart

February 15, 2024 — Abbott announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee ...

Home February 15, 2024
Home
News | Structural Heart

February 9, 2024 — Physicians in the Smidt Heart Institute at Cedars-Sinai have achieved two significant firsts ...

Home February 09, 2024
Home
Subscribe Now