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

ICDs, non-ischemic cardiomyopathy, University of Alabama at Birmingham study, Circulation
News | Implantable Cardioverter Defibrillators (ICD)| January 18, 2017
A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-...
TAVR, medical guidelines, ACC/AHA, optimization, transcatheter aortic valve replacement
News | Heart Valve Technology| January 18, 2017
The American College of Cardiology recently released new guidance for clinicians and hospitals to use in assessing...
stress, brain activity, cardiovascular risk, PET-CT, MGH, ISSMS, The Lancet study
News | Cardiac Diagnostics| January 18, 2017
A study led by Massachusetts General Hospital (MGH) and Icahn School of Medicine at Mount Sinai (ISSMS) investigators...
Medtronic, CoreValve Evolut R 34 mm valve, TAVI, CE Mark, European launch
News | Heart Valve Technology| January 17, 2017
Medtronic plc announced the CE (Conformité Européenne) mark and European launch of the CoreValve Evolut R 34 mm valve...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD)| January 17, 2017
Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac...
University of Utah, Frank Sachse, heart failure, LVAD implantation, left ventricular assist device, biomarker, t-system

Two patients may seem equally sick based upon clinical measures, but differences in their heart physiology could predict who has the potential to recover from heart failure. A study carried out by scientists at the University of Utah finds that patients whose hearts have flattened t-tubules have a decreased chance of showing signs of recovery after implanting a mechanical heart pump. Ordinarily, t-tubules in the heart are long, thin, and rounded. Image courtesy of Frank Sachse.

News | Cardiac Diagnostics| January 17, 2017
Investigators at the University of Utah have identified distinct differences in the hearts of advanced heart failure...
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
St. Jude Medical, Amplatzer Amulet LAA Occluder, observational study, TCT 2016
News | Left Atrial Appendage (LAA) Occluders| November 03, 2016
St. Jude Medical Inc. presented favorable results from the largest observational study to date of the company’s...
Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
open-heart surgery, PCI, percutaneous coronary intervention, NOBLE trial, left main coronary artery disease, LMCAD, TCT 2016
News | Cardiovascular Surgery| November 03, 2016
Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main...
Overlay Init