Biotronik's Oscar catheter receives FDA and CE clearance
Biotronik has announced FDA 510(k) clearance and the CE mark of its Oscar (One Solution: Cross, Adjust, Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases.
As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries.
The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components:
- Oscar support catheter with integrated Lock Grip
- Oscar extendable dilator
- Oscar length-adjustable percutaneous transluminal angioplasty (PTA) balloon
The Oscar system will be available in 11 total size configurations with either 0.014"/4F or 0.018"/6F guidewire/introducer sheath compatibility. This may massively reduce stock units required compared to a standard PTA balloon. Additional standalone Oscar PTA balloons are also available separately to be used with the Oscar support catheter.
The Oscar support catheter and dilator are used in tandem to enable lesion access and crossing with a compatible guidewire, offering a wide range of support strength, adjusted with the extension of the dilator. At its strongest support level, the combination provides up to 55% more pushability than the leading 0.035" support catheter.
Each Oscar multifunctional catheter configuration contains one length adjustable PTA balloon. The physician will simply select the configuration based on the desired balloon diameter. The PTA balloon’s length is adjustable from 20 to 180 mm, allowing users to customise angioplasty by matching the balloon exactly to the lesion length.
The first procedure with the Oscar system in the U.S. was performed by Jihad A. Mustapha, MD, president & chief executive officer and director of endovascular interventions at Advanced Cardiac & Vascular Centres for Amputation Prevention Grand Rapids, Michigan, USA.
Dr Mustapha said: "Oscar is a game-changing product. 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.”
More than 70 cases have been performed in U.S. hospitals with the Oscar device as part of Biotronik pre-launch evaluations. Despite highly complex disease, the Oscar catheter demonstrated a 90% crossing success rate and a PTA technical success rate of 95%. In some cases, physicians had previously tried and failed with traditional crossing devices and strategies.
Dr. Joerg Pochert, president Vascular Intervention at Biotronik, said: "We are thrilled to be leading a change in paradigm for peripheral interventions with the introduction of the Oscar multifunctional peripheral catheter. The new device has the potential to redefine the way physicians approach their complex PAD cases.”
The product will be commercially available in the United States starting in the Spring of 2023 and in CE mark accepting regions in the second half of 2023.