FDA Approves Next-Gen CoreValve Evolut PRO Valve

The move comes just 4 days after new clinical data on the valve were reported at a major medical meeting.

The US Food and Drug Administration (FDA) has cleared Medtronic’s next-generation TAVR valve, the CoreValve Evolut PRO, for patients with symptomatic severe aortic stenosis and a high or extreme surgical risk, the company announced Wednesday.

The self-expanding, repositionable, supra-annular valve has been designed with an outer porcine pericardial tissue wrap intended to improve sealing between the device and the native aortic annulus and to minimize paravalvular leak. It is delivered through the EnVeo R delivery catheter system and is available in 23-, 26-, and 29-mm sizes.

The approval comes just 4 days after researchers presented what the manufacturer says are the first clinical data on the valve at the American College of Cardiology (ACC) 2017 Scientific Session in Washington, DC. Presented as a poster by John K. Forrest, MD (Yale New Haven Health, CT), a single-arm study of 60 patients treated with Evolut PRO demonstrated low rates of mortality (1.7%) and disabling stroke (1.7%) through 30 days, “excellent” hemodynamic results, and a lack of moderate/severe paravalvular leak. Most patients (72.4%) had no/trace leak.

The rate of new pacemaker implantation was 10%, lower than seen in studies of prior-generation devices. In the SURTAVI trial, for example, the pacemaker rate was 25.9% in patients implanted with either the first-generation CoreValve prosthesis or Evolut R.

Sources
  • Medtronic. Medtronic receives FDA approval for CoreValve Evolut Pro transcatheter valve with advanced sealing. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2255774. Published on: March 22, 2017. Accessed on: March 22, 2017.

Disclosures
  • Forrest reports consulting fees and honoraria from Edwards Lifesciences and Medtronic.

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