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# FDA Approves Biotronik PRO-Kinetic Coronary Stent
- URL: https://www.fdaweb.com/fda-approves-biotronik-pro-kinetic-coronary-stent/
- Published: 2017-02-15T12:00:00.000Z
- Updated: 2026-09-14T22:06:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137992

FDA has approved a Biotronik PMA for PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System and its use to improve coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries. The ultra-thin, 60 µm strut thickness of the stent “allows for optimal deliverability under the most extreme conditions of tortuosity and calcification,” the company says. It is indicated for patients who have a blockage in arterial vessels between 2.25 and 4.0 mm in diameter and lesion lengths up to 31 mm.

  
Approval is based on data from the multi-center BIOHELIX–I trial involving 329 patients at 33 sites worldwide. “At nine months, the stent demonstrated a target vessel failure rate of just 9.06%, less than half of the identified performance goal of 18.7%,” Biotronik says. These positive results confirm the clinical success found in other PRO-Kinetic Energy trials. At 12 months, the stent showed a low rate of major adverse cardiac events at 8.1%, including a 4.9% rate of target lesion revascularization, it says.