CE Mark For Direct Flow’s Novel Polymer-Ring-Design Transcatheter Aortic Heart Valve System

In short

California’s Direct Flow Medical®, Inc., has gained CE Mark approval for its distinctive transcatheter aortic heart valve with a metal-free frame and low-profile transfemoral delivery system.


Direct Flow Medical says its Transcatheter Aortic Valve is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves, the main one of which is regurgitation (Post-procedural aortic regurgitation has been shown to be a predictor of long-term mortality).

The system is designed to virtually eliminate aortic regurgitation through a combination of features: With its unique, double-ring design, the valve creates a tight and durable seal around the annulus. It allows complete assessment of haemodynamic performance, repositioning and retrieval after the valve is fully deployed, ensuring optimal positioning, with the knock on effect being minimal regurgitation.

The Direct Flow Medical System also reduces procedural risk by eliminating the need for rapid pacing during deployment and post-dilatation, which are common with other valves and can compromise hemodynamic stability during deployment and positioning.

The Direct Flow Valve System is indeed a clever design, featuring a distinctive, metal-free frame rather than a metal stent. This so-called “polymer frame”, is expanded using pressurised saline and contrast for placement, assessment and repositioning. Once satisfied with the position the saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place.

Study findings

The 30-day, core-lab adjudicated results from the DISCOVER Trial, presented at the 2012 Transcatheter Cardiovascular Therapeutics (TCT) conference, showed that the Direct Flow Medical System achieved 97 percent freedom from all-cause mortality, with 97 percent of patients experiencing no or mild aortic regurgitation.

In addition, total average procedure time was 41.8 minutes with no post-dilatations required. The DISCOVER Trial is a prospective multi-center study conducted at seven leading European cardiology centres. Data from Direct Flow’s first-in-man study, presented at TCT 2012, showed a four-year survival rate of 54 percent, with 80 percent of patients exhibiting no aortic regurgitation, and 20 percent showing trace amounts.

Physician comments

“The Direct Flow Medical System is unique in many ways that combine to virtually eliminate aortic regurgitation, creating greater confidence in the outcome,” said Professor Joachim Schofer, MD, of the Medical Care Center, Hamburg, Germany, and co-principal investigator for the DISCOVER Trial.

“Its novel design enables us to fully assess outcomes and adjust or retrieve the valve at any time during the procedure, without creating hemodynamic stress for the patient,” Schofer added. “This keeps the procedure calm throughout. Delivery is also easy, as the flexible, low-profile design has enabled me to navigate vessels as small as 5.2 mm without vascular complications.”

Source: Direct Flow Medical, Inc., Business Wire