British stone. PAUL, Minnesota--(BUSINESS WIRE)--Cardiovascular Systems Corporation (CSI®) (NASDAQ: CSII) is a medical device company that develops innovative interventional treatment systems for patients with peripheral arterial and coronary artery disease And commercialized it, today announced that the full range of OrbusNeich® JADE® percutaneous transluminal angioplasty (PTA) wire (OTW) balloon catheters are now available in the United States
CSI is the exclusive US distributor of OrbusNeich balloon products.
JADE is an OTW balloon catheter for PTA in the peripheral vascular system, including blocked natural arteries and synthetic arteriovenous dialysis fistulas, as well as balloon expandable and self-expanding stents.
JADE is a non-compliant balloon designed for high pressure tolerance and balloon expansion, with uniform pressure distribution, and used for the treatment of complex lesions. These balloons are compatible with standard 0.014", 0.018" and 0.035" guidewires. The working length of the catheter ranges from 135 cm to 200 cm, and the working length of the balloon ranges from 20 mm to 240 mm.
Dr. Kousta Issa Foteh, Vital Heart and Vein, Dr. Humble, Texas and Siddhartha Rao, Vascular Solutions' Cary, North Carolina, NC are the first two doctors in the United States to adopt the full range of JADE in their respective practices.
Dr. Foteh said: "I would love to add a full range of JADE PTA balloons to my practice. The predictable and uniform inflation of these non-compliant balloons ensures the accuracy of the balloon size and reduces the possibility of vascular rebound. "
Dr. Rao said: "Whether it is on the 0.014", 0.018" or 0.035" platform, the delivery capacity of the JADE balloon is excellent. These balloons have always allowed me to successfully pass through and treat challenging lesions when I have failed with other balloons before. "
CSI Chairman, President and CEO Scott R. Ward said: "We are pleased to announce the full commercial launch of JADE balloons-this is an important supplement to our peripheral product supply. We believe that by offering to save limbs and improve acceptance With a comprehensively differentiated product portfolio for patients with complex peripheral interventional treatments, we will promote meaningful incremental income in peripheral plaque resections."
David Chien, President and CEO of OrbusNeich, said: "The launch of the JADE harness balloon in the United States is an important milestone for OrbusNeich. It will enable us to strengthen our presence in the United States and our existing percutaneous coronary Arterial angioplasty and PTA product portfolio. We believe that the OTW system will meet the needs of many doctors and benefit patients."
About Peripheral Arterial Disease (PAD)
As many as 18 million Americans suffer from PAD, most of whom are over 65 years old. This is due to the accumulation of plaque in the peripheral arteries that reduces blood flow. Symptoms include leg pain when walking or resting. If left untreated, PAD can cause severe pain, inability to move, wounds unable to heal, and eventually amputation. With the increase in risk factors such as diabetes and obesity, the prevalence of PAD is increasing at a double-digit rate.
Millions of PAD patients may benefit from the treatment of orbital plaque resection using Stealth 360® and Diamondback 360® peripheral orbital plaque resection systems (a minimally invasive catheter system developed and manufactured by CSI). These systems use a diamond-coated crown attached to a rotating shaft to grind away dental plaque while preserving healthy blood vessel tissue-a key factor in preventing recurrence. Balloon angioplasty and stents have obvious shortcomings in the treatment of hard calcified lesions. Stents are easy to break and have a high recurrence rate, and the treatment of hard and calcified lesions often leads to vascular damage and sub-optimal results.
Cardiovascular Systems, Inc., located in St. Paul, Minnesota, is a medical device company focused on the development and commercialization of innovative solutions for the treatment of vascular and coronary artery diseases. The company's orbital plaque resection system treats calcified and fibrotic plaques in arteries throughout the legs and heart, and addresses many of the limitations associated with existing surgical, catheter, and drug treatment alternatives. For more information, please visit www.csi360.com and connect on Twitter @csi360.
OrbusNeich is a global pioneer in providing life-changing vascular solutions, offering a broad product portfolio and setting the industry benchmark for vascular interventions. The current products are COMBO® Plus coronary stents, as well as stents and balloons sold under the names AZULE®, SCOREFLEX®, SCOREFLEX® NC, SAPPHIRE® II PRO, SAPPHIRE® 3, SAPPHIRE® II NC, SAPPHIRE® NC Plus and SAPPHIRE ® NC24 and TELEPORT® microcatheters, and products for the treatment of peripheral arterial diseases: JADE® and SCOREFLEX® PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoflaken, the Netherlands; and Tokyo, Japan. OrbusNeich provides medical equipment to doctors in more than 60 countries. For more information, please visit www.OrbusNeich.com.
Certain statements in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the safe harbor protection of forward-looking statements required by the Act. For example, the statements in this press release regarding the benefits of JADE balloon catheters; the commercialization of JADE; and CSI believes that it will drive meaningful incremental revenue from a comprehensive product portfolio. These are forward-looking statements. These statements involve risks and uncertainties that may cause results to differ materially from expected results, including but not limited to the effectiveness of JADE balloon catheters; doctors’ experience with the effectiveness and reliability of products sold by CSI; doctors, hospitals, and other organizations Reluctance to accept new products; the impact of competing products and pricing; and other factors detailed from time to time in CSI's SEC report, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to carefully consider all these risks, uncertainties and other factors when evaluating the forward-looking statements contained in this press release. Due to these matters, changes in facts, unrealized assumptions or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. The forward-looking statements in this press release are made only on the date of this press release, and CSI does not undertake to update them to reflect subsequent events or circumstances.
Indications: JADE PTA balloon dilatation catheter is suitable for percutaneous transluminal angioplasty of the peripheral vascular system, including iliac artery, femoral artery, iliofemoral artery, popliteal artery, inferior popliteal artery and renal artery, as well as treatment of natural or synthetic artery Dialysis fistula for obstructive lesions of the veins. The device is also suitable for post-expansion of balloon expandable and self-expanding stents in the peripheral vasculature.
Contraindications: It is forbidden to use JADE PTA balloon dilatation catheter:
Note: Federal law (U.S.) restricts this device from being sold by doctors or as directed by doctors.
The JADE PTA balloon dilatation catheter was approved by the FDA in 2020.
Cardiovascular Systems, Inc. Jack Nielsen Vice President, Investor Relations and Corporate Communications (651) 202-4919 j.nielsen@csi360.com
CARDIOVASCULAR SYSTEMS, INC. announces the commercial launch of Jade OVER-The-Wire non-compliant peripheral balloon catheter in the United States
Cardiovascular Systems, Inc. Jack Nielsen Vice President, Investor Relations and Corporate Communications (651) 202-4919 j.nielsen@csi360.com