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CoreValve® transcatheter self-expandable aortic bioprosthesis.
Giuseppe Bruschi1, Federico De Marco, Luigi Martinelli
1A. De Gasperis Cardiology and Cardiac Surgery Department, Niguarda Ca' Granda Hospital, Piazza dell'Ospedale Maggiore 3, 20162 Milan, Italy. giuseppe.bruschi@fastwebnet.it
Expert Review of Medical Devices
|January 3, 2013
Summary
Transcatheter aortic valve implantation offers a minimally invasive option for severe symptomatic aortic stenosis patients. The CoreValve device has demonstrated excellent results in over 35,000 patients globally.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Engineering
Background:
- Severe symptomatic aortic stenosis poses significant risks for traditional surgery.
- Transcatheter aortic valve implantation (TAVI) provides an alternative for high-risk patients.
- The CoreValve is a self-expanding nitinol frame device with a porcine pericardial tissue valve.
Purpose of the Study:
- To describe the CoreValve device for transcatheter aortic valve implantation.
- To highlight its CE mark and ongoing US pivotal trial.
- To present its application and outcomes in a large patient cohort.
Main Methods:
- The CoreValve device features a diamond cell nitinol frame and porcine pericardial tissue.
- It is available in four sizes (18-29 mm annulus) and delivered via an 18-Fr catheter.
- Implantation is performed through femoral, axillary, or direct aortic approaches.
Main Results:
- The CoreValve was the first percutaneous valve to receive CE mark for transfemoral implantation (May 2007).
- Over 35,000 patients have been treated worldwide.
- Excellent outcomes have been observed up to 4-year follow-up.
Conclusions:
- Transcatheter aortic valve implantation with the CoreValve is a viable treatment for severe symptomatic aortic stenosis in high-risk patients.
- The device's design and multiple access routes facilitate broad patient applicability.
- Long-term follow-up data indicate favorable results for this minimally invasive procedure.
