Biotronik today released results from the Bioflex-I pivotal clinical trial of its Pulsar-18 self-expanding stent designed for treating patients with peripheral artery disease, touting high rates of freedom from major adverse events and primary patency.
The company claims 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 claims makes the device and associated procedures simple and more efficient.
“More than 8.5 million people in the United States have peripheral artery disease. This patient population deserves innovative treatment options that help them return to their normal activity as quickly as possible. Bioflex-I clinical data confirms Pulsar-18 provides physicians with an effective solution that reduces procedure time and improves outcomes,” prez Marlou Janssen said in a press release.
Data from the trial indicated a 99.7% freedom from major adverse events at 30 days, 87.6% freedom from clinically-driven target lesion revascularization at 12 months and a 66.8% primary patency at 12 months.
“SFA blockages are often challenging to navigate and treat because of the length of the artery and frequent presence of diffuse disease. Reduced blood flow to the limb can lead to amputation, so it is critical that patients are treated quickly and effectively. Because of Pulsar-18’s flexibility, small delivery system and thin struts, the stenting procedure takes less time, reduces complications and allows for earlier patient discharge.” trial principal investigator Dr. Mark Burket said in a prepared statement.
Last month, Biotronik said it won CE Mark approval in the European Union for 3 Tesla full-body scans with its latest range of MR conditional pacemakers featuring its ProMRI technology.