News | May 21, 2009

Direct Flow Medical Completes First Human Use of 18 French Percutaneous Aortic Valve

May 21, 2009 - Direct Flow Medical Inc. this week announced the first human use of its new 18 Fr. Percutaneous Aortic Valve (PAV) System, to successfully treat two high-risk surgical candidates at Dante Hospital in San Paolo, Brazil.

The procedures were performed by Dr. Cesar Esteves and assisted by Dr. Reginald Low and professor Eberhard Grube from the Helios Heart Center in Siegburg, Germany. In the first patient treated with the 18 Fr. PAV system, the physicians were able to safely complete the first successful retrieval of the device through an 18 Fr. sheath before easily positioning and deploying a second device.

The Direct Flow Medical device is a nonmetallic, expandable cuff, bovine pericardial tissue valve that allows the physician to assess the hemodynamic outcomes prior to final deployment of the device. The unique and easily repositionable “stentless” valve conforms to the native annulus resulting in tight sealing of the valve in the annulus, which minimizes any paravalvular leaks. The reduction of aortic insufficiency is believed to improve clinical status in these high-risk patients with significant comorbidities including coronary heart disease and congestive heart failure.

“The improvements in the delivery system from the 22 Fr. to the 18 Fr. system are unparalleled,” Grube said. “The system allows for millimeter control of the device placement and is significantly easier and much more intuitive than the prior system. Finally, the changes to the retrieval system made it much quicker to recover a device and the decision to provide the retrieval device as an accessory significantly reduced the complexity of the 18 Fr. delivery system.”

“The company also endeavored to increase the radial force of the 'stentless' valve,” said Dr. Low. “The deployment of the 18 Fr. PAV required a maximum of three inflations with a valvuloplasty balloon. The resultant mean gradients in these two patients were 8 and 12 mmHg, respectively."

The company recently completed a 31-patient feasibility and safety study at two sites in Germany with its 22 Fr. device in September 2008. Six-month data from this study are being presented this month at both the AATS meeting and the EuroPCR meeting by Dr. Hendrik Treede and professor Joachm Schofer, respectively.

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