VASCULAR SOLUTIONS GETS 510(K) FOR NEW CATHETER
The FDA has given Vascular Solutions 510(k) clearance for its Pronto-Short extraction catheter, a device designed to remove inter-arterial thrombus through a proprietary catheter using syringe aspiration.
The Pronto-Short -- a product line extension of the company's Pronto catheter family -- is specifically designed for use in declotting arterial-venous grafts and fistulas, which are used in hemodialysis procedures and are implanted or created in the patient's forearm. A larger and shorter version of the original Pronto catheter, the Pronto-Short uses a Silva tip to remove thrombus in dialysis grafts and fistulas.
Initial manufacturing quantities of the Pronto-Short have been completed, and initial clinical uses are expected to begin within the next week, the company said. Meanwhile, Vascular Solutions is launching the product immediately through its direct U.S. sales force. It estimates the additive U.S. market opportunity addressed by the product to be approximately $100 million annually.