Feature | November 05, 2012

Direct Flow Medical TAVR System Virtually Eliminates Aortic Regurgitation

No vascular complications reported in DISCOVER CE mark trial

DISCOVER Clinical Trial Direct Medical Trial Direct Flow Medical Transcatheter

November 5, 2012 — Direct Flow Medical Inc. announced that its DISCOVER CE mark trial met its primary mortality endpoint. The study also demonstrated that greater than 95 percent of patients had mild or less aortic regurgitation, and no patients experienced vascular complications. The DISCOVER Trial results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Miami, Fla.

The DISCOVER Trial is a prospective, multicenter study of up to 100 patients conducted at 10 European sites of patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair. The device studied was the Direct Flow Medical Transcatheter Aortic Valve System, which is endovascularly delivered via an 18 French introducer sheath. The trial was initiated in November 2011 and the first patient was treated at the L’Institut Jacques Cartier in Massy, France by Co-Principal Investigator Thierry Lefevre, M.D.

In the presentation of 30-day results for the pre-specified CE cohort of 33 patients reported by Co-Principal Investigator Joachim Schofer, M.D. from the Medical Care Center, Hamburg, Germany, all patients were successfully treated via a transfemoral approach using the low profile, flexible Direct Flow Delivery System. The primary endpoint, freedom from all-cause mortality from procedure to 30 days, was met at 97 percent. Freedom from all cause cardiovascular mortality at 30 days was 100 percent.

Importantly, the Direct Flow Valve resulted in 97 percent mild or less aortic regurgitation, with 81 percent of patients experiencing none/trace aortic regurgitation as reported by the study corelab. There were no major vascular complications in any patients post-procedure through 30 days even though the minimum vessel diameter treated in the study was 5.2 mm. The mean gradient pre-procedure to discharge and out to 30 days of 46, 13.6 and 12.9 mm Hg, respectively, demonstrated the ability to significantly reduce gradients over time. All hemodynamic results were analyzed by an independent imaging core laboratory.

Secondary endpoints (VARC defined Safety) had a combined Safety Rate of 9 percent. In the study, there were two strokes (major or minor) and one patient had a mild myocardial infarction. The device success rate was 97 percent. The average age of patients in the CE mark Cohort was 83 years, with logistic euroSCORE/STS Scores of 27 percent and 11 percent, respectively.

“We are pleased to report the positive initial results for the Direct Flow Valve, as it resolves one of the most important clinical issues in the rtTAVR market today — aortic regurgitation,” said Schofer. “In the trial, we also found that the device was easy to use, offered maximum control and resulted in precise placement. This novel device has the potential to improve clinical outcomes globally and better serve the needs of a growing patient population.”

“We designed the Direct Flow Medical System specifically to address complications that were problematic with earlier generations of transcatheter aortic heart valves,” said Charles Davidson, the company’s chief medical officer, professor of Medicine at Northwestern University Feinberg School of Medicine and clinical chief of Cardiology at Northwestern Memorial Hospital, Chicago, Ill. “Our proprietary design takes a very different approach to restoring valvular flow, while being fully repositionable and retrievable.”

The Direct Flow Medical Transcatheter Aortic Valve System is a novel system utilizing an inflatable cuff with a conforming polymer support structure. Inflatable rings at the top and bottom of the valve are designed to conform and seal above and below the native valve to virtually eliminate aortic regurgitation. The lack of a metallic frame allows for a low profile, flexible, fully-sheathed system with the potential to reduce bleeding and vascular complications, particularly in patients with tortuous and variable anatomy. Full-thickness bovine pericardial leaflets are incorporated in the valve design for durability. The valve can be repositioned even after the implant is fully expanded to its final configuration, providing a unique ability to assess clinical outcomes before final deployment.

For more information: www.directflowmedical.com

Related Content

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...
SENTINEL trial, transcatheter embolic protection, TCEP, TAVR, stroke, TCT 2016
News | Embolic Protection Devices| November 03, 2016
An international study has found that transcatheter cerebral embolic protection (TCEP) is safe, provides effective...
News | Drug-Eluting Balloons| November 03, 2016
The Spectranetics Corp. announced that it has submitted to the U.S. Food & Drug Administration (FDA) its Pre-Market...
Medtronic, Resolute Integrity DES, drug-eluting stent, BIO-RESORT study, TCT 2016
News | Stents Drug Eluting| November 02, 2016
Investigators recently unveiled clinical data from the independent BIO-RESORT study, representing the first all-comers...
Overlay Init