Direct Flow Medical's 29mm Repositionable Transcatheter Aortic Valve Cleared in EU

Direct Flow Medical has announced that European authorities have granted approval to bring to market its 29mm transcatheter aortic heart valve, the only fully repositionable transcatheter valve of this size. The company has been previously cleared to market the 25mm and 27mm versions of its valve in Europe, and the new larger size will allow considerably more patients to benefit from minimally invasive aortic valve replacement.

The prosthetic valve is positioned on top of the natural diseased valve and the inflatable rings assure full contact with the adjacent wall, isolating and rendering irrelevant the original valve.

Here’s an animation demonstrating the implantation of the valve:

 
More from the announcement:

“Until now, patients with large annulus sizes who could not undergo surgical valve replacement had limited options, as other commercially available valves often  leave significant aortic regurgitation at larger sizes and are not repositionable or retrievable,” said Bernard Lyons, President and CEO of Direct Flow Medical. “With the addition of the 29mm valve to our portfolio, we can now greatly improve outcomes for this group of patients, as well.”

The unique, double-ring design of the Direct Flow Medical valve conforms to the anatomy and creates a tight and durable seal around the annulus. The system is designed to improve long term survival of patients by resolving the clinical issues associated with current commercial valves. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. The Direct Flow Medical Transcatheter Aortic Valve System is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR).

Six month data from the DISCOVER CE Mark Trial, recently presented at the 2013 Transcatheter Cardiovascular Therapeutics (TCT) conference, confirm the system’s ability to virtually eliminate significant aortic regurgitation. Through six months, no patient experienced moderate or severe aortic regurgitation and there was a 96 percent overall survival rate, with 90 percent of patients in functional Class I or II.  The system also demonstrated a strong safety profile, with a 97 percent VARC defined Combined Safety rate and no incidence of strokes (major or minor) or myocardial infarction in the evaluable cohort between 30 days and six months.

Flashback: Catheter Delivered Aortic Valve from Direct Flow Medical Wins European Clearance (w/video); Direct Flow Medical Transcatheter Aortic Valve Does Well in Clinical Study; Direct Flow Transcatheter Aortic Heart Valve Gets FDA Feasibility Trial OK

Press release: DIRECT FLOW MEDICAL®, INC. RECEIVES CE MARK FOR FIRST FULLY REPOSITIONABLE 29 MM TRANSCATHETER AORTIC VALVE SYSTEM…