Merit Medical, US-based cardiology, radiology and endoscopy disposable devices manufacturer and distributor, has received multiple regulatory approvals from various regulatory bodies.
Merit’s advanced high-pressure inflation device, called the basixTOUCH, has received 510(k) approval from the US Food and Drug Administration (FDA).
The Touch device, which received the CE mark early in the second quarter of 2013, eliminates the need the use of multiple inflation devices in some advanced interventional cases because of its high pressure range.
Besides, the company has received initial acceptance of a number of claims from its US patent application.
Merit Medical chairman and CEO Fred Lampropoulos said that the features of basixTOUCH 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 our hemostasis valves, to become the largest single revenue producing product in Merit’s history," Lampropoulos added.
Merit has also been notified by its Japanese embolic business partner, Nippon Kayaku, that it has secured nod from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Embosphere(R) and HepaSphere(TM) Microspheres as medical devices, which are used for arterial embolization in patients suffering with hypervascular tumors and arteriovenous malformations.
The shipments of this device will commence in the third quarter of 2013.
The company has received 510(k) clearance from FDA for its Bearing nsPVA Embolization Particles, besides securing approval from the China Food and Drug Administration (CFDA) for its Embosphere product line.