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.

For more information:

Related Content

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Clinical Study | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Clinical Study | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init