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

Sponsored Content | Videos | Angiography| December 07, 2016
Shimadzu's latest generation interventional lab angiography imaging system, the Trinias, enables advanced imaging cap
Lotus Edge valve
News | Heart Valve Technology| December 07, 2016
December 7, 2016 — Boston Scientific announced a definitive agreement to acquire certain manufacturing assets and cap
Impella CP, Abiomed
News | Hemodynamic Support Devices| December 07, 2016
December 7, 2016 — Abiomed Inc. announced it has expanded its U.S.
Vascular Solutions, Teleflex
Feature | December 07, 2016
December 7, 2016 — Teleflex Inc. and Vascular Solutions Inc.
Siemens Healthineers, PURE Platform, angiography, EVAR, CTO, RSNA 2016
News | Angiography| December 07, 2016
December 7, 2016 — At the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (
Spectranetics, Stellarex 0.014-inch DCB, CE Mark
News | Drug-Eluting Balloons| December 06, 2016
December 6, 2016 — The Spectranetics Corp.
TCT 2016, TCT.16, main arena, late breaking trials, transcatheter cardiovascular therapeutics

There were several hot topics that came out of the 2016 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting Oct. 29 - Nov. 2, which made this month's top 20 list, including several videos. Number 4 on the list of content was the result of the EXCEL Trial key TCT late-breaker, which showed stenting is equal in outcomes to surgery for the first time, when using one of the latest generation drug-eluting stents. 

Feature | December 05, 2016
December 5, 2016 — Here is the list of the top 20 most popular pieces of content on the Diagnostic and Interventional
Cardioband, valtech, Edwards Lifesciences, transcatheter mitral repair, transcatheter tricuspid valve repair, transcatheter annuloplasty

An illustration of how the transcatheter Cardioband System can used as a non-surgical form on annuloplasty repair. 

News | Heart Valve Technology| December 02, 2016
December 2, 2016 — Edwards Lifesciences Corp.
Sponsored Content | Videos | Robotic Systems| November 22, 2016
Corindus Vascular Robotics received U.S.
Infinix-i Sky +, RSNA 2016, Toshiba, angiography systems

Toshiba Medical’s Infinix-i product line, including the Infinix-i Sky +, delivers patient access, image quality and safety features for virtually any image-guided procedure, including those in hybrid OR settings.

News | Angiography| November 21, 2016
November 21, 2016 – Healthcare providers seeking versatile imaging technology for their angiography needs can find a
Overlay Init