This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
SOUTH JORDAN, Utah, July 1, 2013 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced 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," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "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 said. "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.