Biotronik’s Passeo-18 Lux DCB Evaluated in Isolated Popliteal Lesions at 24 Months

September 14, 2023—Biotronik announced 2-year results from the BIOLUX P-III BENELUX All-Comers Registry. The prospective, international, multicenter postmarket registry evaluated the safety and efficacy of the company’s Passeo-18 Lux drug-coated balloon (DCB) catheter in isolated popliteal artery lesions. The company noted this indication is considered a difficult vessel bed to treat because of its biomechanical constraints that usually preclude the placement of stents.

Professor Frank Vermassen, MD, who serves as principal investigator of the registry, presented the 2-year data at CIRSE 2023, the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting held September 9-13 in Copenhagen, Denmark. Prof. Vermassen is Chief of Vascular and Thoracic Surgery at UZ Ghent in Ghent, Belgium.

According to the company, the BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, the Netherlands, and Luxembourg. The patients had Rutherford 2 to 5 disease and at least 2 cm of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bailout stenting rate was 14%.

The company reported the following findings at 24 months:

• Freedom from clinically driven target lesion revascularization was 81.6%
• Freedom from major target limb amputation was 98.0%
• Freedom from all-cause of death was 89.4%
• Significant improvement in Rutherford classification was observed for 88.1% of the patients

“We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we don’t want to leave anything behind,” commented Prof. Vermassen, in Biotronik’s press release. “It is encouraging to see that we can safely and effectively treat these lesions with a DCB-only approach.”

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