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

Cardiovascular Systems, Inc. (CSI^®) (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.

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 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, CSI Chairman, 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.”

About Peripheral Artery Disease (PAD)

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.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com and connect on Twitter @csi360.

About OrbusNeich

OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products are the COMBO^® Plus Coronary Stent, together with stents and balloons marketed under the names of AZULE^®, SCOREFLEX^®, SCOREFLEX^® NC, SAPPHIRE^® II PRO, SAPPHIRE^® 3, SAPPHIRE^® II NC, SAPPHIRE^® NC Plus and SAPPHIRE^® NC24 and the TELEPORT^® microcatheter, as well as products to treat peripheral artery disease: the JADE^® and SCOREFLEX^® PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com.

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding the benefits of JADE balloon catheters; the commercialization of JADE; and CSI’s belief that it will drive meaningful incremental revenue from a comprehensive portfolio of products, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the effectiveness of JADE balloon catheters; the experience of physicians regarding the effectiveness and reliability of products sold by CSI; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

Product Disclosure:

Indications: The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

Contraindications: The use of the JADE PTA Balloon Dilatation Catheter is contraindicated:

• for use in the coronary or neuro vasculature; and
• where there is the inability to cross the target lesion with a guidewire.

Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician.

The JADE PTA Balloon Dilation Catheters received FDA clearance in 2020.

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