FDAnews Device Daily Bulletin
Medical Devices / Research and Development

St. Jude Medical Completes First Implants in Pivotal PORTICO Study

May 15, 2014

St. Jude Medical has completed the first implants of its Portico Re-sheathable Transcatheter Aortic Valve System, the first aortic valve that is repositionable until fully deployed, the company said Tuesday.

The prospective, multicenter, randomized, controlled PORTICO trial will evaluate the device’s safety and effectiveness in 1,610 patients who are considered at high or extreme risk for open heart valve replacement surgery. Patients will be randomized according to the appropriate access method and undergo a TAVR procedure using either Portico or an alternative TAVR valve.

Traditional heart valve replacement requires open heart surgery. The Portico valve is delivered to the heart via a catheter threaded through the femoral artery, a minimally invasive procedure, according to St. Jude spokeswoman Micki Sievwright. This allows patients who are typically not candidates for open heart surgery to receive treatment, she said.

The valve is designed to maintain hemodynamics similar to that of a natural valve and addresses issues with early-generation valves, such as the need for a permanent pacemaker and paravalvular leak, St. Jude said.

The 23 mm and 25 mm versions of the device are both CE-marked, and clinical trials are underway to secure the CE mark for additional sizes and delivery approaches, the company said. — Kellen Owings

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