Healthcare Industry News: U.S. Food and Drug Administration
News Release - August 22, 2017
Getinge announces full U.S. availability of Pulsar(R)-18 self-expanding stent from BIOTRONIK for patients with peripheral artery diseaseGetinge expands partnership with BIOTRONIK as part of its commitment to provide healthcare providers with innovative solutions that help improve patient outcomes.
WAYNE, N.J., Aug. 22, 2017 -- (Healthcare Sales & Marketing Network) -- Getinge, a leading global provider of innovative medical technology, today announces the full U.S. market release of the Pulsar®-18 stent from BIOTRONIK. Pulsar-18 is the only available self-expanding stent for blocked superficial femoral arteries with a 4-French (4F) delivery system. Getinge currently distributes BIOTRONIK's portfolio of products to treat peripheral artery disease (PAD) in the United States. The addition of the Pulsar-18 stent to Getinge's portfolio extends the company's commitment to deliver innovative solutions to meet customer and patient needs.
PAD is a serious condition in which atherosclerosis narrows and blocks peripheral arteries, most commonly in the legs. It affects 8 million Americans but is significantly underdiagnosed. Left untreated, PAD can lead to gangrene and amputation because of reduced blood flow.
"Minimally invasive 4-French technology has the potential to positively impact our endovascular practice," said Prof. Marianne Brodmann, Head of Angiology, University Clinic of Graz, Austria, and European Principal Investigator of the BIOFLEX-I study. "Much of the lower limb arterial disease we treat is amenable to 4-French access, thus reducing risks associated with access site complications compared to larger bore devices and offering similarly promising efficacy even in complex lesions."i
"As more patients are diagnosed with PAD due to our aging population, interventional and surgical teams need access to innovative, proven peripheral vascular products that meet the needs of a range of patient types," said Raoul Quintero, President Americas at Getinge. "Adding the Pulsar-18 stent to our robust vascular interventions portfolio supports our passion and commitment to help healthcare providers improve patient care while reducing costs."
"With the recent FDA approval of our Pulsar-18 stent, clinicians have access to a 4-French solution that eliminates the need for closure devices, allows for early ambulation, and potentially reduces time to discharge for PAD patients," said Marlou Janssen, President of BIOTRONIK, Inc. "These are benefits that can improve procedure safety and efficiency and truly impact quality of life for patients with PAD. The Pulsar-18 stent needs to be immediately accessible to physicians, and our partnership with Getinge will allow this to happen."
About the Pulsar-18 Stent
The Pulsar-18 stent, approved by the U.S. Food and Drug Administration (FDA) on March 23, 2017, was developed by BIOTRONIK, a global leader in cardio- and endovascular medical technology. Pulsar-18 is the only self-expanding stent for the superficial femoral artery approved by the FDA with a 4F delivery system, which enables simpler, safer and more efficient procedures than larger diameter delivery systems. With Pulsar-18, procedure times are reduced because the 4F system more easily crosses lesions,ii lowers access site complication rates, and requires less compression time without the need for a closure device.iii
The safety and efficacy of the Pulsar-18 stent for blocked superficial femoral arteries was demonstrated by 12-month data from the pivotal BIOFLEX-I clinical study, presented during the C3 summit 2017 by BIOFLEX-I US Principal Investigator Mark Burket, MD, FACC, FSCAI, University of Toledo Medical Center. Results showed 99.7 percent freedom from major adverse events (MAEs) at 30 days, 87.6 percent freedom from clinically-driven target lesion revascularization (TLR) at 12 months, and 66.8 percent 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 the ankle-brachial index (ABI), six-minute walk and walking impairment questionnaire (WIQ).iv
About Getinge's Vascular Interventions Portfolio
Getinge offers a full line of peripheral vascular products for interventional procedures performed in the cath lab, as well as the FUSION BIOLINE, FLIXENE and HEMASHIELD family of vascular grafts and patches. Getinge's portfolio also includes BIOTRONIK's peripheral vascular product line, which includes the Astron iliac self-expanding stent, the Passeo PTA balloon family and the Fortress family of reinforced sheaths.
Getinge is a global provider of innovative solutions for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Based on our first-hand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving the every-day life for people, today and tomorrow.
i Bosiers et al. Results of the 4EVER trial. J Endovasc Ther. 2013;20:746-756.
ii BIOTRONIK data on file (6.0 mm diameters).
iii Bosiers M, et al. 4-French–compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: Results of the 4-EVER Trial. Endovasc Ther. 2013;20:746-756.
iv Presented in a late-breaking session at the 2017 Complex Cardiovascular Catheter Therapeutics Advanced Endovascular and Coronary Intervention Global Summit (C3).
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.