Feature | June 03, 2013

Medtronic CoreValve System Receives CE Mark for Transcatheter Valve-in-Valve Procedures

Replacing degenerated surgical valves with CoreValve results in hemodynamic improvements for patients

June 3, 2013 — Medtronic Inc. announced it has received CE mark for valve-in-valve (VIV) procedures using the CoreValve and CoreValve Evolut transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves. This is the first regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated. The CoreValve VIV procedures are not approved in the United States.

Results from the largest global VIV registry, published in Circulation in November (“Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results from the Global Valve-in-Valve Registry”), showed the VIV approach resulted in considerable hemodynamic (blood flow) improvements, including a decrease in valve gradients (blood flow resistance). Positive procedural outcomes were maintained at one-year follow-up (with 89 percent survival at one year), which was comparable with other non-VIV TAVI studies.

“While surgical valves provide effective therapy for many patients, the replacement valves eventually degenerate over time, so VIV has become a topic of great clinical interest due to the needs of these patients,” said Ran Kornowski, M.D., chair of cardiology at Rabin Medical Center and Tel-Aviv University in Tel-Aviv, Israel, and senior author of the Global Valve-in-Valve registry. “European approval of the CoreValve procedure is a very important advance in the treatment of severe aortic stenosis and enables an entirely new group of patients to benefit from this transcatheter valve.”

The Global VIV registry evaluated the safety and efficacy of the VIV approach in 202 patients at 38 sites in Europe, North America, Australia, New Zealand and the Middle East, with 124 patients receiving the CoreValve system. In the study, the CoreValve system demonstrated superior hemodynamic outcomes and high procedural success rates (96.8 percent).

The valve-in-valve procedure, in which the CoreValve system is placed inside the degenerated surgical aortic valve through a low-profile, 18 French delivery catheter, is approved for use with all four CoreValve sizes (23 mm, 26 mm, 29 mm and 31 mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic access).

“We are pleased to now extend this safe and less invasive, valve-in-valve procedure. This approach allows patients to avoid a second open-heart surgery to replace a failing surgical valve, which was originally performed to replace their own diseased valve.” said John Liddicoat, M.D., senior vice president of Medtronic, and president of the Medtronic Structural Heart Business. “Furthermore, the impressive improvements in hemodynamic performance, due to CoreValve’s supra-annular design, are showcased in the results of these valve-in-valve procedures.”

Each year approximately 200,000 people worldwide receive surgical aortic valves, which typically last 15 years or more. When the surgical valves degenerate due to the aging process, patients require another valve replacement. However, some patients are not eligible for a second open-heart surgery, and the transcatheter VIV procedure now may provide them with a new treatment option.

The Medtronic CoreValve system is available in the United States for investigational use only. In the Medtronic CoreValve U.S. Expanded Use Study, the U.S. Food and Drug Administration (FDA) has approved investigational VIV procedures in extreme-risk patients (part of the pivotal trial evaluating the CoreValve system in the United States).

For more information: www.medtronic.com

Related Content

Montreal Heart Institute Performs First Robotic Mitral Valve Surgery
News | Robotic Systems| September 22, 2017
The Montreal Heart Institute (MHI) announced the acquisition of the da Vinci Xi, a new-generation surgical robot, and...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Overlay Init