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: www.directflowmedical.com

Related Content

Edwards, Sapien 3 transcatheter heart valve, Canada, approval
News | Heart Valve Technology| July 27, 2016
Edwards Lifesciences Corp. announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for...
PCI outcomes, public reporting, high-risk patients, JAMA Cardiology, Beth Israel Deaconess Medical Center study
News | Cath Lab| July 27, 2016
July 27, 2016 — A number of states mandate public reporting of mortality outcomes following certain cardiac procedure
News | Genetic Testing| July 26, 2016
July 26, 2016 — A new study has identified a genetic error that weakens the aorta, placing patients with this and sim
heart failure, after first heart attack, cancer risk, JACC study
News | Cardiac Diagnostics| July 21, 2016
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared...
mitral valve surgery outcomes, twisting of the heart, echocardiography, NICSMR, JACC Basic to Translational Science
News | Heart Valve Technology| July 20, 2016
A novel study has found a simple pre-operative echocardiographic measurement of the amount of torsion of the heart...
TITAN II Trial, Carillon Mitral Contour System, Cardiac Dimensions, Open Heart journal, functional mitral regurgitation, FMR
News | Annuloplasty Rings| July 20, 2016
New data from the TITAN II trial confirm the safety and efficacy of the Carillon Mitral Contour System in the treatment...
Mitralign, Trialign system, tricuspid regurgitation. SCOUT U.S. study, phase 1 enrollment
News | Heart Valve Technology| July 19, 2016
Mitralign Inc. announced last week it has completed subject enrollment in the SCOUT early feasibility study in the...
sudden cardiac arrest, out-of-hospital, comatose patients, University of Arizona study, wake up
News | Sudden Cardiac Arrest| July 13, 2016
Physicians may be drawing conclusions too soon about survival outcomes of patients who suffered a cardiac arrest...
radial access, inserting stents, JACC Cardiovascular Interventions study
News | Radial Access| July 13, 2016
A new study in JACC: Cardiovascular Interventions supports access through the wrist, or radial access, as the default...
University of Guelph study, heart failure risk, gender, aging
News | Heart Failure| July 08, 2016
University of Guelph researchers have uncovered a possible clue as to why women have lower rates of heart failure than...
Overlay Init