Getinge (PINK:GETI B) said today it launched Biotronik‘s Pulsar-18 self-expanding stent in the US, operating as Biotronik’s distributor in the region for its portfolio of peripheral artery disease devices.
Biotronik claims that the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with a 4-French delivery system, which it said makes the device and associated procedures simple and more efficient.
“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. 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,” Getinge America’s prez Raoul Quintero said in a press release.
“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. 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,” Biotronik prez Marlou Janssen said in a prepared statement.
Last month, Biotronik released results from the Bioflex-1 pivotal trial of the Pulsar-18, touting high rates of freedom from major adverse events and primary patency.
“Minimally invasive 4-French technology has the potential to positively impact our endovascular practice. 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,” Bioflex-I study primary investigator Marianne Brodmann of Austria’s University Clinic of Graz said in a prepared statement.
