BD Launches UltraScore 014 Focused Force PTA Balloon
April 1, 2019—BD (Becton, Dickinson and Company) announced the launch of its UltraScore 014 Focused Force percutaneous transluminal angioplasty (PTA) balloon. The device is a scoring balloon with sheath compatibility as small as 4 F and is now available in the United States.
According to BD, the UltraScore Focused Force PTA balloon is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries and treat obstructive lesions of native or synthetic arteriovenous dialysis fistulas. The device is also recommended for postdilatation of balloon-expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.
The company explained that the UltraScore Focused Force PTA balloon is designed to longitudinally fracture plaque at lower inflation pressures compared to standard PTA and may allow for more controlled plaque fracture and less vessel recoil, even in calcified lesions.
The device is available in both 0.014- and 0.035-inch guidewire platforms, with sizes ranging from 2.0 to 8.0 mm in diameter and up to 300 mm in length. Both UltraScore 035 and UltraScore 014 devices have received European CE Mark approval and FDA 510(k) clearance.
In BD's announcement, William Bachinsky, MD, commented, “The deliverability, ease of use, and expansion of the vessel with UltraScore Focused Force PTA balloon are excellent. The addition of UltraScore 014 Focused Force PTA balloon will fit right in with our treatment algorithms for popliteal and infrapopliteal lesions.” Dr. Bachinsky is Director, Cardiac and Vascular Interventional Program at UPMC Pinnacle in Harrisburg, Pennsylvania.