FDA Clears Merit Medical's Bearing nsPVA Embolization Particles and Inflation Device

July 1, 2013—Merit Medical Systems, Inc. (South Jordan, UT) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Bearing nsPVA embolization particles.

As described in the company's website, Bearing nsPVA embolization particles are irregularly shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters. The Bearing nsPVA product has also received CE Mark approval in Europe.

Merit Medical also announced that the company's basixTouch high-pressure inflation device received 510(k) clearance from the FDA. The company stated that the basixTouch eliminates the need to use multiple inflation devices in some advanced interventional cases because of its high-pressure range. The device has been launched in Europe, where it received CE Mark approval early in the second quarter of 2013.

Merit was also notified by its embolic business partner in Japan—Nippon Kayaku Co., Ltd. (Tokyo, Japan)—that it has received approval from the Japanese Pharmaceuticals and Medical Devices Agency for Merit's Embosphere and HepaSphere microspheres as medical devices for the purpose of arterial embolization in patients with hypervascular tumors and arteriovenous malformations. The China Food and Drug Administration has renewed its clearance of Merit's Embosphere product line, the company advised.