Merit Medical Secures Multiple Regulatory Approvals
Merit Medical Systems has received multiple regulatory approvals from various regulatory bodies in US, Japan and China. The basixTOUCH, Merit's most advanced high-pressure inflation device, has received 510(k) clearance from the FDA. 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. The features of this device can also be applied to other inflation products such as the Blue Diamond digital inflation system. This device and its derivatives have the potential, when combined with other devices, such as the companyâs haemostasis valves.
Merit also reported 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 embolisation in patients with hypervascular tumours and arteriovenous malformations.
The company also reported that it has received 510(k) clearance for its Bearing nsPVA embolisation particles. The embolic product (CE mark approved), which was developed at its French facility, adds an additional product to Merit's portfolio to complement its Embosphere, HepaSphere and QuadraSphere product offerings. Additionally, the China Food and Drug Administration (CFDA) has renewed its clearance of Merit's Embosphere product line.