Biotronik’s Passeo-18 Lux DCB Evaluated at 2 Years in BIOPACT RCT

November 27, 2023—Biotronik announced the presentation of 2-year results from the investigator-initiated BIOPACT randomized controlled trial (RCT). The noninferiority trial evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic) in the treatment of femoropopliteal lesions. Excellent results were demonstrated for both balloons through 24 months, reported the company.

The findings were presented by BIOPACT Principal Investigator Koen Deloose, MD, at the Paris Vascular Insights 2023 congress held November 8-10 in Paris, France. Dr. Deloose is Head of the Department of Vascular Surgery, AZ Sint Blasius Hospital in Dendermonde, Belgium.

According to the company, the prospective, multicenter, core-lab adjudicated noninferiority BIOPACT RCT enrolled 302 patients in Austria, Belgium, France, and Switzerland with Rutherford class 2-4 disease.

Patients were randomized 1:1 to either the Passeo-18 Lux DCB or In.Pact Admiral DCB for the treatment of stenotic, nonstented restenotic, or occlusive lesions in the femoropopliteal artery. Baseline patient and lesion characteristics were comparable across both arms.

As presented by Dr. Deloose, the rate of clinically driven target lesion revascularization (CD-TLR) for the Passeo-18 Lux DCB was noninferior compared to the In.Pact Admiral DCB at 12 months and noninferiority was maintained at 24 months (93.3% vs 94.6%). Survival was also equivalent at 24 months, with a 95.0% rate of overall survival for both devices. There were no major target limb amputations in either arm.

“The 2-year results of the BIOPACT RCT have continued to demonstrate the noninferiority of the safety and efficacy of the Passeo-18 Lux DCB to the In.Pact Admiral DCB, and they show persistent excellence of both devices,” commented Dr. Deloose in Biotronik’s press release. “This study is critically needed to fill the gap of head-to-head data for peripheral DCBs to keep the most effective treatments accessible to our patients.”

The company stated that the BIOPACT RCT study will continue collecting data at 36, 48, and 60 months, which will be shared upon completion of each follow-up period.

According to Biotronik, the Passeo-18 Lux DCB has a paclitaxel dose of 3.0 µg/mm² and uses a butyryl-tri-hexyl citrate excipient. The lower-profile Passeo-18 Lux DCB is on a 0.018-inch platform and is 4-F compatible for diameters of 2.0 to 4.0 mm and 5-F compatible for diameters of 5.0 to 7.0 mm.

By comparison, the In.Pact Admiral DCB has a paclitaxel dose of 3.5 µg/mm² and uses a urea excipient. It is 5-F compatible only for its 4.0-mm diameter, and is 6-F or 7-F compatible for its diameters of 5.0 to 7.0 mm.

The Passeo-18 Lux paclitaxel-releasing percutaneous transluminal angioplasty balloon catheter is not available for sale or use in the United States, advised Biotronik.