Biotronik completes enrolment for Biolux P-I study

Biotronik has completed enrolment for a new clinical trial called Biolux P-I, a study that will utilise drug-eluting balloon (DEB) catheters to treat peripheral artery disease.

The company's Passeo-18 Lux DEB catheter will be used in a randomised controlled trial comparing it to an uncoated percutaneous transluminal angioplasty catheter, for the treatment of lesions in the femoropopliteal segment.

A total of 60 European patients have been enrolled for the study, which will evaluate the safety and efficacy of the therapy in terms of angiographic late lumen loss at six months.

It is thought that DEB therapy can be an effective and durable new option for patients with de novo and restenotic arterial disease in the lower limbs, while helping to avoid restenosis following treatment.

Alain Aimonetti, vice-president of sales and marketing for Biotronik's vascular intervention division, said: "Our significant investment in clinical research continues to demonstrate Biotronik's dedication to leading the industry in finding solutions for improved patient outcomes."

Earlier this month, the company published results from a study called Prevent, which demonstrated the benefits of its Intrinsic Rhythm Support algorithm technology for pacemakers.