Current regulatory news

FDA APPROVALS

Boston Scientific Corp. received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for isolating pulmonary veins in treating drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique, new alternative to standard-of-care thermal ablation treatment.

The FARAPULSE PFA System delivers pulsed field energy and consists of the FARAWAVE Ablation Catheter, the FARASTAR Ablation Generator, and the FARADRIVE Steerable Sheath, which is complemented by the VersaCross Connect Access Solution for the FARADRIVE Steerable Sheath to provide safe and efficient access to the left side of the heart during procedures with the system. The FARAWAVE catheter can treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to adapt to individual patient anatomies. These configurations reinforce ease-of-use for physicians and promote reproducible procedures between operators.
https://www.bostonscientific.com

W. L. Gore & Associates Inc. received U.S. Food and Drug Administration (FDA) approval of a lower profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft). No changes to the stent design were made to achieve the lower profile. By focusing on improvements to the delivery system only, the valued characteristics and trusted performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides.

Since its U.S. launch in 2017, more than 375,000 VBX Stent Grafts have been implanted worldwide. Currently in the U.S., the device is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters from 5mm to 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.
https://www.goremedical.com/products/vbx

Tyber Medical LLC received a U.S. Food and Drug Administration (FDA) 510(k) approval for a line extension to the existing, approved Mini-Frag System, with additional screw and plate options, and indications. This additional clearance expands Tyber Medical products’ healing capabilities and adds to their restorative portfolio.

The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions and fusions in the hand, wrist, foot, and ankle. The Anatomical Plating System provides versatility, precision, and efficiency in one system, and is offered in titanium and stainless-steel.

The line extension to the Mini-Frag System includes 1.3mm screws and plates, expanding the range of sizes in the Tyber Medical Mini-Frag System.
https://tybermedical.com