Biotronik’s Oscar Multifunctional Peripheral Catheter Gains FDA Clearance and CE Mark

February 14, 2023—Biotronik announced it has received FDA 510(k) clearance and CE Mark for its latest device, the Oscar multifunctional peripheral catheter.

According to the company, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature, and it was developed to provide support during access into and dilate stenoses in femoral, popliteal, and infrapopliteal arteries.

The Oscar catheter comprises three user-adjustable components: a support catheter with integrated lock grip, an extendable dilator, and a length-adjustable percutaneous transluminal angioplasty (PTA) balloon.

The PTA balloon’s length is adjustable from 20 to 180 mm, allowing users to customize angioplasty by matching the balloon exactly to the lesion length.

Biotronik reported the Oscar system will be available in 11 total size configurations with either 0.014-inch/4-F or 0.018-inch/6-F guidewire/introducer sheath compatibility. Additional standalone Oscar PTA balloons are also available separately to be used with the Oscar support catheter, stated the company.

Jihad A. Mustapha, MD, performed the first procedure with the Oscar system in the United States.

“In cases where we had previously failed with multiple treatment approaches, the Oscar catheter made it possible to succeed while also saving time and reducing how long the patient needs to spend on the table. This is one of the best support systems I’ve ever used, and the length-adjustable balloon functionality is exceptional.” Dr. Mustapha is Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, Michigan.

As part of Biotronik’s prelaunch evaluation, > 70 cases using Oscar were performed in United States hospitals. According to data on file at Biotronik, testing performed using a 0.018-inch/6-F Oscar catheter demonstrated a 90% crossing success rate and a PTA technical success rate of 95%.

Biotronik noted in its announcement that the Oscar system will be commercially available in the United States starting in Spring 2023 and in CE Mark–accepting regions in the second half of 2023.