Press release

BIOTRONIK announces first patient enrollment in the BIOLUX P-I clinical study investigating drug-eluting balloon therapy for peripheral artery disease

BUELACH, Switzerland, November 4, 2010 - BIOTRONIK AG, a European manufacturer of therapy solutions for vascular intervention, announced the first enrollment in the BIOLUX P-I clinical study—a milestone that further reinforces the company’s position as a leader in providing proven, high quality technologies for patients with peripheral vascular disease.

BIOLUX P-I is a randomized controlled study investigating the safety and performance of the BIOTRONIK Passeo-18 Lux, a drug-eluting balloon (DEB) catheter, versus a noncoated percutaneous transluminal angioplasty (PTA) catheter, for the treatment of lesions in the femoropopliteal segment. The primary endpoint of BIOLUX P-I is late lumen loss (LL) at six months as documented by angiography. The primary investigator for the study is Professor Dierk Scheinert, Head of Angiology Dept, Herzzentrum/Park Krankenhaus, Leipzig, Germany.

The first patient was enrolled by the team of Professor Karl-Ludwig Schulte, Vascular Center Berlin/Ev. Krankenhaus Königin Elisabeth Herzberge, Germany. “As expected, the procedure went very well,” commented Professor Schulte. “The Passeo-18 Lux balloon catheter is based on a platform technology that has had a highly reliable performance history. We are now quite interested to observe the postprocedural effects that the drug may have on therapy efficacy.”

In the peripheral vessels, drug-eluting balloons hold great promise as effective and durable treatment options for treating patients with de novo and restenotic arterial disease in the lower limbs. Restenosis following treatment with standard PTA balloons is a significant risk, and it is anticipated that delivery of a drug to the lesion location could significantly improve therapy efficacy.

“BIOTRONIK is very committed to bringing proven, high quality therapies to patients with vascular disease,” commented Alain Aimonetti, Vice President of Sales and Marketing. “We are unrivaled in our innovative offering of ultralow profile 4 F peripheral devices, and with the BIOLUX P-I trial, it is also our aim to firmly establish BIOTRONIK’s growing reputation as a leader in clinical research for peripheral vascular disease. We have invested significantly in perfecting the drug-device combination therapy delivered by the Passeo-18 Lux balloon catheter, and we expect this trial to demonstrate the importance for physicians to have such a device available to them.”

Passeo-18 Lux is based on Passeo-18, BIOTRONIK’s established 0.018 in. guidewire-based PTA balloon. It is coated with a homogeneous layer of the proven drug Paclitaxel combined with a carrier for increased bioavailability and optimized antiproliferative effect. The drug-carrier combination has already demonstrated early clinical efficacy in the recently presented first-in-man study PEPPER, investigating BIOTRONIK’s Pantera Lux DEB in coronary in-stent restenosis.

Upon CE certification, Passeo-18 Lux will complement BIOTRONIK’s comprehensive peripheral portfolio, alongside innovative devices such as Pulsar-18, the world’s first fully 4 F compatible self-expanding stent up to 200 mm from 4.0 mm to 7.0 mm diameter.
 

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,400 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

 

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