The Brescia, Italy-based Invatec has recently launched operations in the U.S., and its new CEO, Jack Springer, discussed with Cardiovascular Business News the current trek for product launches and regulatory approvals for the parent companies’ line of peripheral and coronary devices.
In May, Invatec began building a U.S. team, hiring Springer, opening a U.S. headquarters in Bethlehem, Pa., and beginning the process of gaining regulatory approval for both its coronary and peripheral product lines. “From a financial standpoint, it makes sense from both the clinical and regulatory requirements, as well as from a sales perspective, to have a direct organization in the country.” He added that the company hopes to build relationships with U.S. physicians for future product development.
Invatec began distributing its peripheral product line in the U.S. through ev3 in the fourth quarter of 2004, which marked the company’s introduction into the market. Springer explained that about a year ago, Invatec decided to begin selling its FDA-approved lines independently. “It was time to begin the push to get their additional product lines, available in Europe, on the path toward regulatory approval in the U.S.,” according to Springer.
As a result of the new company, ev3 will cease distributing Invatec products as of Dec. 31.
Springer said that they are just beginning to sell the balloon lines that have been previously sold by ev3, such as the Admiral Xtreme 0.035-inch OTW PTA balloon catheter; the Amphirion Deep 0.014-inch OTW/RX PTA infrapopliteal balloon catheter; SubMarine Rapido RX PTA balloon catheter; as well the Diver CE rapid-exchange clot extraction catheter device. For these lines, the company has hired a direct sales and marketing group of approximately 25 people.
Simultaneously, the company is conducting the ARMOUR study for its Mo.Ma proximal flow blockage cerebral protection device, which Invatec said protects patients during embolization with proximal flow blockage. “The idea for this device came from working with our European physicians, who were seeking protection for the carotid artery by preventing emboli from going downstream,” Springer said. Mo.Ma was first introduced in the European market in 2001, after multiple clinical studies that reported on its safety and efficacy.
The ARMOUR study now aims to confirm safety and efficacy of Mo.Ma in patients at high-surgical carotid risk undergoing carotid stenting with any FDA approved carotid stent. Recruitment in ARMOUR study is progressing within 25 investigational sites in the U.S. and Europe under the guidance of principal investigators Gary Ansel, MD, from Riverside Methodist Hospital in Columbus, Ohio, and L. Nelson Hopkins, MD, from University of Buffalo in Buffalo, N.Y.
Springer predicts that the trial will be completed in January or February of 2009, and the data will be available to submit to the FDA in the May of 2009. The ARMOUR trial embraced a total study population of 228 patients with a 30-day follow-up. He is hoping for FDA approval by the fourth quarter of next year.
While Springer acknowledged that launching Invatec’s coronary product line in the U.S. might be further downstream, the process is part of the overall corporate strategy, along with possibly opening a research and development component, in order to foster interaction with U.S. physicians.