BD has announced the launch of their UltraScore 014 Focused Force percutaneous transluminal angioplasty (PTA) Balloon. This marks the first scoring balloon with sheath compatibility as small as 4F on the US market.
The UltraScore balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature. UltraScore 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. With the addition of the 0.014” guidewire platform, the device is available in both 0.014” and 0.035” solutions with sizes ranging from 2mm to 8mm in diameter and up to 300mm in length.
“The deliverability, ease of use and expansion of the vessel with UltraScore Focused Force PTA Balloon are excellent,” commented William Bachinsky, director of the Cardiac and Vascular Interventional Program at UPMC Pinnacle. “The addition of UltraScore 014 Focused Force PTA Balloon will fit right in with our treatment algorithms for popliteal and infrapopliteal lesions.”
Both UltraScore 035 and UltraScore 014 devices are CE-marked and have received 510(k) clearance by the US Food and Drug Administration (FDA).