Merit Medical Earns Multiple Regulatory Approvals

Merit Medical Systems Inc. details out the receipt of multiple regulatory approvals from various regulatory bodies.

Merit Medical Systems Inc. officials announce that it has received multiple regulatory approvals from various regulatory bodies.

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 U.S. 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," states Fred P.

Lampropoulos, Merit's chairman and CEO. "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 our hemostasis valves, to become the largest single revenue producing product in Merit's history."

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 (PMDA) for

Embosphere and HepaSphere Microspheres as medical devices for the purpose of arterial embolization in patients with hypervascular tumors and arteriovenous malformations.

"We are pleased with the substantial efforts of our partner to bring this highly needed product to the people of Japan," Lampropoulos states.

"Initial shipments are scheduled to begin in the third quarter of 2013."

Merit also announced that it has received 510(k) clearance for its Bearing nsPVA Embolization Particles.

"This embolic product, which was developed in our French facility, 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 (CFDA) has renewed its clearance of Merit's Embosphere product line.

"We believe the efforts of our regulatory staff and business partners worldwide will enhance our business prospects and growth moving forward," Lampropoulos concludes.

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