Cardiovascular Systems Acquires WIRION Embolic Protection System from Gardia Medical to Enhance Procedural Safety in Peripheral Interventions

On August 6, 2019, VCBeat (WeChat ID: vcbeat) learned that Cardiovascular Systems acquired the WIRION Embolic Protection System and related assets from Gardia Medical, a medical device company under Allia Medical Solutions.

Following this acquisition, Cardiovascular Systems will transfer the commercial production of the WIRION Embolic Protection System to the United States, with the entire transition process expected to be completed within 12 to 15 months. Gardia will retain the rights to use the WIRION system during carotid angioplasty and stenting procedures.

Gardia Medical, a medical device startup founded in 2009 and headquartered in Israel, is dedicated to the development and commercialization of catheter delivery systems for cardiovascular interventional procedures. The company’s catheter delivery system enables the delivery, locking, and deployment of devices at any position along the guidewire during minimally invasive interventional surgeries. Additionally, Gardia manufactures embolic protection devices; its WIRION system received CE marking in June 2015 and FDA approval in March 2018.

The WIRION Embolic Protection System is a distal embolic protection system. This system is indicated for the removal of embolic material, such as thrombus, during carotid angioplasty, stenting, and atherectomy of calcified lesions in the lower extremities. The WIRION system is easier to use than other embolic protection systems, is suitable for all types of peripheral interventions, and is the only embolic protection device indicated for use with atherectomy. The WISE LE study demonstrated that the major adverse event (MAE) rate for WIRION was 1.9%, which is generally lower than that of other embolic protection systems. No significant distal embolization was observed with the use of WIRION.

Dr. Ehrin Armstrong, a medical professor at the University of Colorado, stated, “The use of embolic protection devices during peripheral interventions with a high risk of embolism can help control procedural complications.”

Cardiovascular Systems, a medical device company founded in 1989 and headquartered in Minnesota, USA, is dedicated to the development and sale of medical devices for the treatment of cardiovascular diseases. The company’s Orbital Atherectomy System (OAS) can treat calcified or fibrotic plaques in the arterial vessels of the legs and heart within minutes. To date, Cardiovascular Systems has sold over 450,000 medical devices to leading institutions worldwide.

Asaf Alperovitz, CEO of Allium Medical Solutions, stated, “Allium Medical’s mission is to develop innovative products that improve patient outcomes worldwide. We believe that Gardia Medical’s WIRION system will be highly synergistic with Cardiovascular’s growing product portfolio. We will continue to collaborate with Cardiovascular and ensure the timely completion of the WIRION transition.”

Scott Ward, Chairman and Chief Executive Officer of Cardiovascular Systems, stated, “The acquisition of the WIRION system enables us to further fulfill our mission of building a comprehensive and differentiated product portfolio to improve the lives of patients worldwide.”

(Compiled by Hu Yifan)