News | February 24, 2015

Analyst Says European Market Could Facilitate Prosthetic Heart Valve Advancements

Transcatheter mitral valve replacement (TMVR) device makers likely to utilize Europe’s relatively lax regulatory approval process for new product testing

TMVR, Europe, heart valve repair, GlobalData

February 24, 2015 — In light of a recent American Heart Association report stating that U.S. mitral valve regurgitation prevalence was 1.7 percent in 2014, a significant opportunity exists for development of an effective transcatheter mitral valve replacement (TMVR) device as an alternative treatment to surgery for inoperable patients. This assessment was given by an analyst with research and consulting firm GlobalData.

Furthermore, according to Premdharan Meyyan, GlobalData's analyst covering medical devices, TMVR device makers are expected to utilize the relatively lax regulatory approval process in the European market to test new products and amass clinical data; first-generation devices are likely to be approved within the next five years.

Mitral valve regurgitation patients comprise the largest segment of the U.S. population suffering from heart valve-related disorders. Some of them cannot be treated by conventional surgical repair methods due to associated comorbidities or other risk factors, creating a need for minimally-invasive therapies that will ultimately improve clinical outcomes.

“Following the shake-up of the surgical heart valve market with the emergence of minimally-invasive transcatheter aortic valve replacement (TAVR) procedures, key opinion leaders have asserted that a similar opportunity exists for companies to discover the easiest and safest way to put devices into the mitral position," said Meyyan.

“Although the complex anatomy of the mitral annulus makes successful implantation of a prosthetic device in this position more difficult than in the aortic position, major prosthetic heart valve manufacturers, such as Edward Lifesciences, are already executing TMVR development alongside their existing product lines,” Meyyan added.

The analyst adds that numerous smaller companies, including Neovasc and Micro Interventional Devices, are making a focused effort to develop technologies that overcome the clinical barriers specific to mitral valve replacement.

“While these devices are still years away from commercialization, early movers in the TMVR space are poised to seize considerable shares from key players in the billion-dollar prosthetic heart valve market, due to the large patient base,” Meyyan concluded.

For more information:

Related Content

Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation
Feature | Heart Valve Technology | December 12, 2018
A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S....
First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.
News | Heart Valve Technology | November 06, 2018
4Tech Inc. initiated its U.S. Early Feasibility Study of the TriCinich Coil System following U.S. Food and Drug...
Valve Replacement Volume Key to Successful Patient Outcomes
News | Heart Valve Technology | November 02, 2018
Hospitals that routinely perform a heart valve replacement procedure requiring open heart surgery are more likely to...
Prosthetic Valve Mismatches Common in TAVR Procedures
News | Heart Valve Technology | October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and...
Local Anesthesia Safe and Effective for Intermediate- and High-Risk TAVR Patients
News | Heart Valve Technology | September 28, 2018
The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (...
MitraClip Reduces Mortality for Heart Failure Patients With Secondary Mitral Regurgitation
News | Heart Valve Technology | September 26, 2018
Patients with heart failure and secondary mitral regurgitation (MR) who remained symptomatic despite maximally...
Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Overlay Init