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Biotronik enrols first patient in Passeo-18 Lux trial
Biotronik has announced the enrolment of its first patient for a new clinical study of Passeo-18 Lux, its new drug-eluting balloon catheter treatment for peripheral artery disease.
The company is commencing the Biolux P-I study in order to evaluate the medical device compared to a noncoated percutaneous transluminal angioplasty catheter for treating lesions in the femoropopliteal segment.
It is thought that the balloon, by delivering drugs straight to the lesion location, can help to improve treatment efficacy while reducing the associated risk of restenosis.
Professor Karl-Ludwig Schulte of the Vascular Center Berlin/Ev Krankenhaus Konigin Elisabeth Herzberge, whose team implanted the device in the first trial patient, said the procedure went "very well".
Alain Aimonetti, vice-president of sales and marketing at Biotronik, added: "We expect this trial to demonstrate the importance for physicians to have such a device available to them."
Last month, the company announced the European launch of the Thoracic Impedance Trend Chart, a new diagnostic enhancement to its Heart Failure Monitor device.
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