Getinge Announces Full Availability of Biotronik's Pulsar-18 Self-Expanding Stent in the United States
August 22, 2017—Getinge, which distributes Biotronik's portfolio of products to treat peripheral artery disease in the United States, announced the full United States market release of Biotronik's Pulsar-18 self-expanding stent with 4-F delivery system for use in the superficial femoral arteries (SFAs).
Getinge stated that the Pulsar-18 device with 4-F delivery system reduces procedure times, more easily crosses lesions, lowers access site complication rates, and requires less compression time without the need for a closure device.
In July, Biotronik announced the results of the BIOFLEX-I clinical study and the commercial availability of Pulsar-18, which was approved in March 2017 by the US Food and Drug Administration for the treatment of SFAs.
According to Getinge, the safety and efficacy of the Pulsar-18 stent for treating the SFAs were demonstrated by 12-month data from the pivotal BIOFLEX-I clinical study presented by the trial's United States Principal Investigator Mark Burket, MD, at C3: the 2017 Complex Cardiovascular Catheter Therapeutics Advanced Endovascular and Coronary Intervention Global Summit held June 27–30 in Orlando, Florida.
The BIOFLEX-I results showed 99.7% freedom from major adverse events at 30 days, 87.6% freedom from clinically driven target lesion revascularization at 12 months, and 66.8% primary patency at 12 months in lesion lengths up to 190 mm. Results also demonstrated improvements in clinical and quality-of-life metrics as assessed by ankle-brachial index, 6-minute walk test, and a walking impairment questionnaire.
In Getinge's announcement, Professor Marianne Brodmann, MD, European Principal Investigator of the BIOFLEX-I study, commented, "Minimally invasive 4-F technology has the potential to positively impact our endovascular practice. Much of the lower limb arterial disease we treat is amenable to 4-F access, thus reducing risks associated with access site complications compared to larger bore devices and offering similarly promising efficacy even in complex lesions."