BIOTRONIK is releasing its new Pulsar-18, a self-expanding stent designed for placement within the superficial femoral artery (SFA). This is the only FDA approved device of its kind to fit inside a 4 French sized delivery catheter, making it easier to get it through difficult lesions and place it accurately at the target location.
The device features struts only 140 μm in width and a low “Chronic Outward Force” that helps to prevent damage to the interior of the vessel, speed up healing, and hopefully lower the chances of further blockages near the stent.
“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,” said BIOFLEX-I US Principal Investigator Mark Burket, MD, FACC, FSCAI. “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.”
Recently 12-month data came in from a large clinical study of the stent being used on lesions as long as 190 cm. Here are some results:
- 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
- 66.8 percent primary patency at 12 months
Some of the device features according to the product page:
- One-handed stent release for accurate stent deployment
- Low profile 4 F delivery system with stents of up to 7 x 200 mm
- S-articulating connecting bars and peak-to-valley design for multi-directional flexibility
- Segmented stent design with thin struts for lower restenosis rates
Product page: Pulsar-18…