BIOTRONIK Announces Improved Patient Outcomes with Innovative "Combination Therapy" for Peripheral Artery Disease

Treatment Combining Passeo-18 Lux Drug-Coated Balloon with Pulsar-18 Stent Led to Excellent Patency and Safety

Vascular Intervention: BIOTRONIK Announces Improved Patient Outcomes with Innovative "Combination Therapy" for Peripheral Artery Disease

November 20, 2015 — BIOTRONIK has presented the 24-month results from the DEBAS clinical trial at the VEITH symposium. DEBAS is the first investigator-initiated trial to demonstrate the efficacy and safety of a novel combination therapy for peripheral artery disease (PAD) using Passeo-18 Lux drug-coated balloon (DCB) and Pulsar-18 self-expanding stent (SES) to treat peripheral artery disease in a complex patient population.

“BIOTRONIK’s DCB as well as SES have been proven to work as individual treatments for superficial artery disease. However, each approach has its respective limitations in certain vessel morphologies and clinical situations,” stated DEBAS principal investigator

Dr. Patrice Mwipatayi, Royal Perth Hospital, Perth, Australia. “The results of DEBAS indicate that a hybrid approach combining Passeo-18 Lux with the thin-strut stent, Pulsar-18 may overcome some of these limitations and improve patients’ clinical outcomes, especially for the long and complex lesions seen in this trial.”

A total of 65 patients were enrolled in the prospective, multicenter, investigator-initiated DEBAS registry, with 24-month data available for 51 patients. More than half of the patients were treated for long, complex TASC D lesions, indicative of an advanced disease state. All patients were treated with the Pulsar-18 stent followed by Passeo-18 Lux DCB. The primary endpoint was primary patency at 12 months with follow-up to 24 months. At 12 months, primary patency was very high at 92.2 percent, sustained at 88.2 percent at 24 months. Major amputation was 1.96 percent at 24 months, confirming the safety of combination therapy with Passeo-18 Lux and Pulsar-18.

“Pulsar-18’s thin strut design makes this stent uniquely suited for adjunctive therapy with DCB, as thinner struts decrease the distance between the DCB’s coating and the vessel wall. A low metal-to-artery ratio guarantees that the drug can be delivered to the vessel wall following stent implantation,” explained Dr. Mwipatayi. “Additionally, Pulsar-18’s thin struts may have a ’scoring effect’ on the lesion when the Passeo-18 Lux is inflated within the stent, potentially reducing barotrauma, or injury caused by inflation of a DCB. These factors might improve drug uptake and lead to the outstanding primary patency seen in this trial.”

“Passeo-18 Lux and Pulsar-18 represent key technologies in the BIOTRONIK peripheral portfolio. They have a documented history of clinical success when used as individual treatment options, and the highly encouraging results of DEBAS show that combination therapy with both can achieve even better clinical performance,” commented Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “BIOTRONIK has established a rigorous clinical program to more fully investigate combination therapy as an alternative to existing drug-eluting approaches.”

About Passeo-18 Lux

Passeo-18 Lux is a novel combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on that of the proven Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of anti-proliferative paclitaxel and butyryl-tri-hexyl citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. This coating is also applied to Pantera Lux, a clinically proven coronary drug-coated balloon. Passeo-18 Lux also features the unique SafeGuard insertion aid, which improves ease of handling and protects the user and balloon coating from contact and damage. After use, SafeGuard can simply be peeled away.

About Pulsar-18

Pulsar stents feature an innovative, highly flexible design coated with proBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility, which is believed to contribute to its excellent clinical results. Pulsar-18 is available in diameters of 4 to 7 mm, all deliverable through a 4 F sheath.