Tag Archive for Vascular Surgery

Laminate Medical’s VasQ Fistula Supporting Device Gets FDA Investigational Device Exemption

Laminate Medical Technologies, an Israeli firm, won an Investigational Device Exemption (IDE) from the FDA to begin a clinical trial of its VasQ device designed to support arteriovenous fistulas. The technology will hopefully benefit patients that receive hemodialysis via AVF in the upper extremity. In many dialysis patients the fistulas that (Read more...)

Stellarex Drug-Coated Balloon for PAD Approved by FDA

Spectranetics, based in Colorado Springs, Colorado, won FDA approval to bring to the U.S. market its Stellarex drug-coated balloon catheter. The device is designed and indicated for helping to restore and keep open the lumen of superficial femoral and popliteal arteries in patients with peripheral artery disease. The device features the compan (Read more...)

BIOTRONIK’s Pulsar-18 Stent with Thin Delivery System for Superficial Femoral Arteries Now Available

BIOTRONIK is releasing its new Pulsar-18, a self-expanding stent designed for placement within the superficial femoral artery (SFA). This is the only FDA approved device of its kind to fit inside a 4 French sized delivery catheter, making it easier to get it through difficult lesions and place it accurately at the target location. The dev (Read more...)

DABRA Laser Ablates Blocked Arteries

Ra Medical, a company out of Carlsbad, California, received FDA clearance and is reporting the first commercial use of its DABRA laser-based arterial blockage ablation system. Unlike most other intravascular tools used for removing arterial plaque that rely on mechanical methods, the DABRA is an excimer laser that emits at a wavelength of 308 nm, [ (Read more...)

Clarius Wireless, Handheld Ultrasounds Cleared in Europe

Clarius, a company based in British Columbia, Canada, received European CE Mark approval for its wireless C3 and L7 ultrasound scanners. These devices are highly portable, battery powered, and use an Android or iOS smartphone or tablet for displaying the scans. They’re even water resistant, so can be used in a wide variety of in-clinic a (Read more...)

Gore VIABAHN VBX Balloon Expandable Stent Graft First to Get FDA Approval for Iliac Arteries

Gore won FDA approval for its VIABAHN VBX endoprosthesis to be used in the iliac arteries, making it the only balloon expandable stent graft having such an indication. It can be used on new or restenotic lesions within the iliac, including at the aortic bifurcation. Previously, vascular surgeons were only able to do such procedures […]

This (Read more...)