BIOLUX 4EVER Will Evaluate Combined Treatment With Biotronik's Pulsar-18 Stent and Passeo-18 Lux Balloon for SFA Disease

July 17, 2014—Biotronik announced that the first patient has been enrolled in the investigator-initiated BIOLUX 4EVER trial, which is evaluating the combined use of the company’s Pulsar-18 self-expanding stent and Passeo-18 Lux drug-releasing balloon to see if the outcomes could be improved further on the positive results from each of the previous drug-releasing balloon (DRB) and self-expanding stent trials.

According to the company, BIOLUX 4EVER will follow the study design of the previously completed, investigator-initiated 4EVER trial, which examined the efficacy of the Pulsar; the new trial will add the Passeo-18 Lux DRB to the treatment. The study will enroll 120 patients treated with both devices. The primary endpoint is 12-month primary patency. The study’s principal investigator is Marc Bosiers, MD, of St. Blasius Hospital in Dendermonde, Belgium.

In Biotronik’s press release, Dr. Bosiers commented, “Studying these two devices in combination is a novel idea. Previous studies of each device have yielded encouraging results, but we wanted to go one step further. Now, patients will be treated with both the Pulsar-18 stent and the Passeo-18 Lux, hopefully pushing the results off the charts.”

BIOLUX P-I was the first in-human study investigating the performance of the Passeo-18 Lux DRB compared to an uncoated Passeo-18 balloon catheter in the treatment of SFA lesions. At 12 months, freedom from target lesion revascularization was achieved in 84.6% of DRB patients and 58.3% of percutaneous transluminal angioplasty patients.

The 4EVER study investigated both the acute and long-term performance of 4-F–compatible devices in treating SFA lesions. The study examined the efficacy of Pulsar stents and the feasibility of treating patients with Biotronik 4-F devices. At 24 months, the full cohort of 120 patients in the 4EVER trial showed a 72.3% primary patency rate and a freedom from target lesion revascularization rate of 82.7% with no significant difference between calcified and noncalcified lesions.

Pulsar stents feature a highly flexible design coated with ProBio, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility. Pulsar-18 is available in diameters of 4 to 7 mm and lengths of 20 to 200 mm, all deliverable through a 4-F sheath.

Passeo-18 Lux is a combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on the Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of antiproliferative paclitaxel and butyryl-tri-hexyl-citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. Passeo-18 Lux’s insertion aid improves ease of handling and protects the user and balloon coating from contact and damage, stated Biotronik.