Merit Medical Systems has announced that it has received multiple regulatory approvals from regulatory bodies in the USA, Europe, Japan and China.
The Basixtouch, a high-pressure inflation device, has received 510k clearance from the US Food and Drug Administration. The “Touch”, which attained the CE mark early in the second quarter of 2013, has had substantial success in the first two months of its European release. The “Touch” eliminates the need to use multiple inflation devices in some advanced interventional cases because of its high pressure range. The company also received initial acceptance of a number of claims from its US patent application.
“We believe the introduction of the Basixtouch clearly places Merit in the worldwide leadership position for inflation devices which are used in numerous interventional and peripheral procedures,” said Fred P Lampropoulos, Merit’s chairman and chief executive officer.
Merit also announced that it has been notified by its embolic business partner in Japan, Nippon Kayaku, that it has received approval from Japan’s Pharmaceuticals and Medical Devices Agency for Embosphere and HepaSphere microspheres as medical devices for the purpose of arterial embolization in patients with hypervascular tumours and arteriovenous malformations. “Initial shipments are scheduled to begin in the third quarter of 2013,” Lampropoulos said.
Merit also announced that it has received 510(k) clearance for its Bearing nsPVA embolization particles.
“This embolic product adds an additional product to our portfolio to complement our Embosphere, HepaSphere and QuadraSphere product offering,” Lampropoulos said. “The Bearing nsPVA has broad appeal worldwide and has also received the CE mark.”
Finally, the China Food and Drug Administration has renewed its clearance of Merit’s Embosphere product line.