February 17, 2016 — Biotronik announced a partnership with Maquet Medical Systems USA to distribute Biotronik peripheral vascular devices in the United States.
The two companies will deliver a range of Biotronik products used to treat peripheral artery disease (PAD). These include the Passeo percutaneous transluminal angioplasty (PTA) balloon family; the Fortress reinforced sheath; the Cruiser-18 guide wire; and the Astron stent, which was recently granted U.S. Food and Drug Administration (FDA) approval for the treatment of iliac artery disease. This is Biotronik’s first FDA approval for a peripheral stent product.
Atherosclerotic disease of the iliac arteries, which supply blood to the pelvic organs and much of the lower limbs, can greatly impact a patient’s overall quality of life, limiting walking ability and leading to chronic pain and even morbidity. Endovascular interventions, including angioplasty and stenting, have become the first-line approach for the treatment of patients with simple and complex peripheral atherosclerotic lesions, including challenging-to-access iliac lesions. In 2014, an estimated 176,800 patients in the United States received an iliac stent, and that number is expected to grow annually.
“The Astron stent is a proven option for treating atherosclerotic disease of the common or external iliac arteries. Results of a 12-month study of Astron demonstrated a major adverse event (MAE) rate of just 2.1 percent, which is remarkably lower than the pre-specified performance goal of 15 percent,” said Mark W. Burket, M.D., of the University of Toledo Medical Center in Ohio, and national principal investigator of the BIOFLEX-I IDE study, which evaluated the performance of the Astron stent. “Astron’s 12-month target lesion revascularization rate was also low, at 1.4 percent. Based on these excellent results, I believe that U.S. physicians and patients will welcome this new technology.”
The Astron self-expanding nitinol stent system is designed to provide the specific performance characteristics required for iliac arteries. It features a peak-to-valley stent design with S-shaped articulating connecting bars to provide multi-directional flexibility while avoiding fish-scaling in tortuous arteries. The segmented architecture and strut thickness are engineered to provide optimal chronic outward force.
Astron stents are manufactured with Biotronik’s unique proBIO coating, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue.
For more information: www.biotronik.com