Cardiovascular Systems paid $5.6 million for the system and $1.5 million will be held in escrow until the 12 months following a successful manufacturing transfer. The company also issued Gardia 31,493 shares of common stock of Cardiovascular Systems pursuant to an exemption from registration, according to an SEC filing.
“The acquisition of the Wirion System further supports our commitment and mission of building a comprehensive portfolio of differentiated products aimed at saving limbs and improving the outcome for patients undergoing complex peripheral interventions,” president and CEO Scott Ward said in a press release.
Wirion is a distal embolic protection filter that is used to capture debris associated with all types of peripheral vascular intervention procedures. The device is typically used in vessels above the knee with long lesions, high plaque burden and poor runoff.
“The use of an embolic protection device during peripheral interventions where the risk of embolization is higher provides assurance and protection from procedural complications,” professor of medicine at the University of Colorado Ehrin Armstrong said.
The Wirion System can be used with any .014 in. guidewire and for all types of peripheral interventions. It received CE Mark approval in June 2015 and FDA clearance in March 2018.
“Allium Medical’s mission is to develop innovative products to improve outcomes for patients around the world,” Asaf Alperovitz, CEO of Allium Medical Solutions, which wholly owns Gardia Medical, said. “We believe the Wirion System is the only embolic protection device indicated for use with any atherectomy system. The Wise LE study also demonstrated a major adverse event rate of 1.9%, which is lower than any other previously reported rates with other embolic filters. Importantly, no clinically significant distal embolization was observed when the Wirion System was used.”
Cardiovascular Systems said it plans to commercialize the system in the U.S. after it transfers manufacturing from Gardia Medical. The company expects the transfer to be completed after a 12- to 15-month transition period. Through the deal, Gardia will retain the rights to the system for angioplasty and stenting procedures in the carotid arteries.
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