Feature | February 01, 2013

Direct Flow Medical Receives CE Mark for Transcatheter Aortic Heart Valve

Clinicians can fully assess and optimize patient outcomes before valve is secured in place

Direct Flow Medical Transcatheter Aortic Valve System CE mark

February 1, 2013 — Direct Flow Medical Inc. has received CE mark for its distinctive transcatheter aortic heart valve with metal-free frame and low-profile transfemoral delivery system. The Direct Flow Medical transcatheter aortic valve system is designed to virtually eliminate aortic regurgitation by allowing complete assessment of hemodynamic performance, repositioning and retrieval after the valve is fully deployed in the native valve annulus. The double ring design of the valve creates a tight and durable seal around the annulus. The system is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.

Two sizes of valves – 25 mm and 27 mm – will be commercially available in Europe immediately; both are delivered via a flexible, 18 French system.

Post-procedural aortic regurgitation has been shown to be a predictor of long-term mortality.[1] 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.[2]

In addition, total average procedure time was 41.8 minutes with no post-dilatations required.[2] The DISCOVER trial is a prospective multicenter study conducted at seven leading European cardiology centers. 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.[4]

“The Direct Flow Medical system is unique in many ways that combine to virtually eliminate aortic regurgitation, creating greater confidence in the outcome,” said Joachim Schofer, M.D., 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.” 

The Direct Flow Medical system also reduces procedural risk by eliminating the need for rapid pacing during deployment[3] and post-dilatation, which are common with other valves and can compromise hemodynamic stability during deployment and positioning.

To support European commercialization, the company has also announced the appointment of Dan Rose as vice president of sales and marketing. Most recently, Rose was vice president of commercial operations for Sequana Medical, a Swiss medical device company developing proprietary implantable pump systems. Prior to that, Rose held a number of sales and marketing leadership positions at Medtronic in Europe in both the interventional cardiology and cardiac surgery businesses.

“Dan is an experienced medical device executive who understands how to market novel cardiovascular technologies and commercialize in diverse and competitive international markets,” said Bernard Lyons, CEO of Direct Flow Medical. “His experience positioning innovative cardiovascular devices to drive clinical adoption will contribute to our success as we launch in Europe.”

The benefits of the Direct Flow Medical transcatheter aortic valve system are enabled by its design, which features a distinctive, metal-free frame. Rather than a metal stent, the system incorporates a polymer frame, which is expanded using pressurized saline and contrast for placement, assessment and repositioning. The saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. The double-ring design of the valve creates a tight and durable seal around the annulus. Three hollow positioning wires allow for the fluid exchange and also uniquely enable distal, proximal and planar repositioning. The metal-free design enables an 18 French, fully sheathed delivery system that has been proven to minimize vascular complications and improve hemodynamic outcomes.[2]

For more information: www.directflowmedical.com

References:

[1] Kodali S, Williams M  Smith C, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366(18):1686-1695.

[2] Schofer J, Fajadet J, Colombo A, et al. 30-day outcome of the 18F-Direct Flow Medical valve in patients with aortic stenosis – results from the DISCOVER trial. JACC 2012;60(17):B236

[3] Schofer J, Schlüter M Treede H, et al. Retrograde transarterial implantation of a nonmetallic aortic valve prosthesis in high-surgical-risk patients with severe aortic stenosis – A first-in-man feasibility and safety study. Circ Cardiovasc Intervent 2008;1:126-133.

[4] Bijuklic K, Tuebler T  Treede H, et al. Long term performance of a transfemorally implantable nonmetallic, retrievable and repositionable aortic valve in patients with severe aortic stenosis - 4 year follow-up of the 22F-Direct Flow Medical valve. JACC 2012;60(17):B236.

Related Content

Reducing Secondary Mitral Regurgitation in Heart Failure Does Not Improve Two-year Outcomes
News | Heart Valve Technology | September 11, 2019
Percutaneous reduction of secondary mitral regurgitation in patients with heart failure does not lower death and...
Abbott Launches Pivotal Trial of TriClip Tricuspid Valve Repair System
News | Heart Valve Technology | September 05, 2019
Abbott announced the launch of the company's TRILUMINATE Pivotal trial evaluating the safety and effectiveness of its...
An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire

An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire is electrified to lacerate the leaflet, and the the leaflet splays after TAVR permitting coronary flow.

Feature | Heart Valve Technology | August 27, 2019
A novel technique has proven successful in preventing coronary artery obstruction during transcatheter aortic valve r
Edwards Recalls Sapien 3 Ultra Delivery System Due to Burst Balloons During Surgery
News | Heart Valve Technology | August 22, 2019
Edwards Lifesciences is recalling the Sapien 3 Ultra delivery system after receiving reports of burst balloons during...
FDA Approves Sapien 3, CoreValve Evolut TAVR Valves for Low-risk Patients

Left, an illustration of the beginning of deployment for a CoreValve Evolut self-expanding transcatheter aortic replacement (TAVR) valve. Right, an illustration of the final balloon expansion of an Edwards Lifesciences Sapien 3 TAVR valve. Both valves received simultaneous FDA clearance for use in low-risk surgical patients. Clearing this last hurdle now allows wide-spread use of minimally invasive TAVR in all patients who otherwise would need an open-heart surgical valve replacement. 

Feature | Heart Valve Technology | August 16, 2019 | Jeff Zagoudis, Associate Editor, and Dave Fornell, Editor
In one coordinated move, the U.S. Food and Drug Administration (FDA) opened transcatheter aortic valve replacement (...
Abbott Receives U.S. Approval of Next-generation MitraClip G4
Technology | Heart Valve Technology | July 17, 2019
Abbott has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip heart valve repair...
Neovasc Tiara, Reducer Transcatheter Devices Featured at CSI Frankfurt 2019 Conference
News | Heart Valve Technology | July 09, 2019
Neovasc Inc. announced that its Tiara transcatheter mitral valve replacement (TMVR) device and its Neovasc Reducer...
Study Shows Inducing a Heart Attack Helps Valve Patients. This image shows a left-ventricular outflow tract (LVOT) obstructed by an Edwards Sapien TAVR valve used for a valve-in-valve procedure. The arrow points to the small, crescent shaped dark area of the neo-LVOT, which did not allow enough blood to flow from the left ventricle into the aorta and the rest of the body. To prevent this issue, the procedure used by Henry Ford ablates some of the tissue in the septum to allow for a larger LVOT area.

This image shows a left-ventricular outflow tract (LVOT) obstructed by an Edwards Sapien TAVR valve used for a valve-in-valve procedure. The arrow points to the small, crescent shaped dark area of the neo-LVOT, which did not allow enough blood to flow from the left ventricle into the aorta and the rest of the body. To prevent this issue, the procedure used by Henry Ford ablates (kills) some of the tissue in the cardiac septum to allow these valves to fit better and allow for an enlarged neo-LVOT for patients who otherwise could not receive this therapy. 

News | Heart Valve Technology | July 03, 2019
A study of a procedure developed at Henry Ford Health System shows inducing a heart attack in patients with heart...
CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement
Feature | Heart Valve Technology | June 24, 2019
The Centers for Medicare and Medicaid Services (CMS) recently finalized its decision to update the national coverage...
Overlay Init