Cardiovascular Systems Announces U.S. Commercial Launch of JADE Over-the-Wire Non-Compliant Peripheral Balloon Catheters

Cardiovascular Systems, Inc. (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the full line of OrbusNeich® JADE® percutaneous transluminal angioplasty (PTA) over-the-wire (OTW) balloon catheters is now available in the U.S.

Cardiovascular Systems is the exclusive U.S. distributor of OrbusNeich balloon products.

JADE is an OTW balloon catheter for PTA in the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae, as well as for post-dilatation of balloon expandable and self-expanding stents.

JADE is a non-compliant balloon designed for high pressure tolerance and balloon dilatation with even pressure distribution for the treatment of complex lesions. These balloons are compatible with standard 0.014”, 0.018” and 0.035” guidewires, and with catheter working lengths ranging from 135 cm to 200 cm and balloon working lengths from 20 mm to 240 mm.

Dr. Kousta Issa Foteh, Vital Heart and Vein, Humble, Texas and Dr. Siddhartha Rao, Vascular Solutions of North Carolina, Cary, N.C., were two of the first physicians in the U.S. to adopt the full line of JADE in their respective practices.

Said Dr. Foteh, “I was eager to add the full line of JADE PTA balloons to my practice. The predictable, uniform inflation of these non-compliant balloons allows for accuracy in balloon sizing and reduces the potential for vessel recoil.”

Said Dr. Rao, “The deliverability of the JADE balloons, whether it be on the 0.014”, 0.018” or 0.035” platform, is exceptional. These balloons have consistently allowed me to cross and treat challenging lesions successfully in situations where I would have previously failed with other balloons.”

Scott R. Ward, Cardiovascular SystemsChairman, President and Chief Executive Officer, said, “We are excited to announce the full commercial launch of the JADE balloons – an important addition to our peripheral product offering. We believe we will drive meaningful incremental revenue in our peripheral atherectomy cases by offering a comprehensive portfolio of differentiated products designed to save limbs and improve outcomes for patients undergoing complex peripheral interventions.”

David Chien, OrbusNeich President and Chief Executive Officer, said, “The launch of the JADE over-the-wire balloons in the U.S. is a significant milestone for OrbusNeich that will allow us to strengthen our presence in the U.S. alongside our existing percutaneous transluminal coronary angioplasty and PTA portfolio. We are confident that the OTW system will address many physicians’ needs and benefit patients.”

 

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