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

News | Pharmaceuticals| September 26, 2016
Nearly 2 out of 5 people with diabetes who could benefit from statin therapy to lower their risk of future heart attack...
smartphones, hospital tranfers, heart attack patients, JACC study, South Korea
News | Mobile Devices| September 23, 2016
Smartphone communication among medical teams at different hospitals can significantly reduce the time it takes for...
Medtronic, In.Pact Admiral drug-coated balloon, trial data, VIVA
News | Drug-Eluting Balloons| September 22, 2016
New data presented at the Vascular Interventional Advances (VIVA) conference demonstrated the durability, consistency...
4Tech, TriCinch TTVR, transcather tricuspid valve repair device, first implant
News | Heart Valve Technology| September 22, 2016
4Tech Inc. announced that its TriCinch device has been used in the world’s first-ever successful transcatheter...
Transesophageal Echo, TEE. Interventional echocardiography, interventional echo, Philips, CX50

Transesophageal echo (TEE) has become an essential part of the new transcatheter structrual heart therapies, giving rise to a new sub-speciality of interventional echocardiography.  

Feature | Cath Lab Navigation Aids| September 21, 2016 | Dave Fornell
The rapid growth of transcatheter structural heart procedures and the need for increased use of echocardiography as a
Claret Medical, Sentinal CPS, cerebral protection system, FDA marketing application, TAVR, embolic protection
News | Embolic Protection Devices| September 20, 2016
Claret Medical announced its filing of a marketing application with the U.S. Food and Drug Administration (FDA) for...
Medtronic, CRT, cardiac resynchroniazation therapy devices, heart failure, medication adherence, retrospective analysis, HFSA 2016
News | Heart Failure| September 20, 2016
Medtronic plc announced the results of an analysis that reveals patients increasingly adhere to heart failure...
Edwards sapien, intermediate risk patients, CE mark
News | Heart Valve Technology| September 20, 2016
September 19, 2016 — Edwards Lifesciences received European CE mark to expand use of the Edwards Sapien 3 transcathet
Lotus Edge Valve, CE mark, boston scientific, TAVR, TAVI

The Lotus Edge system in its deployed position. The Lotus valve expands outward as it is compressed and buckled in the deployment position. It also has a skirt to help eliminate paravalvular leaks.

News | Heart Valve Technology| September 19, 2016
September 19, 2016 — Boston Scientific received European CE mark approval for its Lotus Edge Valve System, the compan
Valtech Cardio, Cardioband Tricuspid, Cardioband Mitral, PCR London Valves 2016, study data
News | Heart Valve Technology| September 19, 2016
Valtech Cardio Ltd. announced that it will present the first-in-man data for its Cardioband Tricuspid (TR) system at...
Overlay Init