Cardiovascular Systems Launches OTW Peripheral Balloon Catheters

Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, has launched the full line of OrbusNeich JADE percutaneous transluminal angioplasty (PTA) over-the-wire (OTW) balloon catheters in the United States.
 
CSI 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 United States 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.”

As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
 
Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue—a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.
 
The JADE PTA Balloon Dilation Catheters received FDA clearance in 2020.
 
Scott R. Ward, CSI Chairman, president and CEO, 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 CEO, 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.”