Cardiovascular Systems (CSI) has purchased the Wirion embolic protection system and related assets from Gardia Medical for an undisclosed sum.
Wirion secured CE mark approval in June 2015, while clearance from the US Food and Drug Administration (FDA) in March 2018.
CSI chairman, president and CEO Scott Ward said: “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 outcomes for patients undergoing complex peripheral interventions.”
Wirion embolic protection system
Wirion is a distal embolic protection filter designed to capture debris, which can be associated with all types of peripheral vascular intervention (PVI) procedures.
The physicians generally use embolic protection devices in vessels situated above the knee with long lesions, high plaque burden and poor run off.
The company has designed the Wirion system to use with any .014” guidewire, as well as for all types of peripheral interventions.
Wirion is claimed to be the only embolic protection device indicated for use with any atherectomy system. The WISE LE study also showed a major adverse event (MAE) rate of 1.9%, which is lower than any other previously reported rates with other embolic filters, said the company.
Following the transfer of manufacturing from Gardia Medical, CSI intends to commercialise the Wirion system in the US. Gardia will hold the rights to the Wirion system for angioplasty and stenting procedures in the carotid arteries.
Allium Medical Solutions, a parent firm of Gardia Medical, CEO Asaf Alperovitz said: “Allium Medical’s mission is to develop innovative products to improve outcomes for patients around the world.
“We believe the WIRION System from Gardia Medical, one of our portfolio companies, will be highly synergistic with CSI’s growing portfolio of products. We will continue to partner with CSI to execute a timely manufacturing transfer and get the product in the hands of physicians.”
In June this year, CSI has enrolled first patient in the REACH PVI study, which aimed at evaluating the acute clinical outcomes of orbital atherectomy through transradial access for the treatment of peripheral artery disease (PAD) in lower extremity lesions.
