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 the full market release of the 2.00 Max Crown for Peripheral Orbital Atherectomy Systems (2.00 Max Crown).
Built on the proven Diamondback 360® Orbital Atherectomy platform, the 2.00 Max Crown is uniquely designed to enable simultaneous modification of both intimal and medial calcium. The new 2.00 Max Crown features an increased 70-micron diamond coated crown that creates more efficient engagement in mixed plaque, helping to achieve optimal luminal gain in mild to moderately calcified lesions above the knee.
Dr. Amit Srivastava, MD, FACC, FABVM at Bay Area Heart Center in St. Petersburg, Fla., was one of the first physicians in the U.S. to incorporate the 2.00 Max Crown into his practice.
Said Dr. Srivastava, “The new 2.00 Max Crown greatly expands the lesions that can be treated with CSI’s Orbital Atherectomy. This device delivers exceptional luminal gain in mixed morphology lesions above the knee.”
Scott R. Ward, Chairman, President and Chief Executive Officer of CSI, said, “The full commercial launch of the 2.00 Max Crown represents another important product launch for CSI as we broaden and diversify our product offering. Our peripheral orbital atherectomy systems can now treat a wider range of plaque morphologies throughout the leg. Combining this new device with our full line of interventional support devices, we continue to advance the ability of physicians to improve outcomes for patients undergoing peripheral interventions.”
About Peripheral Artery Disease (PAD)
Eighteen to 20 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.
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 more information, visit www.csi360.com and follow us on LinkedIn and Twitter.
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 commercial introduction of 2.00 Max Crown, the impact of this new product, and the broadening and diversification of CSI’s product offering, 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 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; general economic conditions; 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.
CSI® and Diamondback 360® are trademarks of Cardiovascular Systems, Inc.
The Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series, which includes the Max*, Solid, Classic and Micro crowns, is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. Contraindications for the system include for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
*The 2.00 Max Crown has not been tested to support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).
See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
The 2.00 Max Crown received FDA 510(k) clearance.
Cardiovascular Systems, Inc.
Vice President, Investor Relations & Corporate Communications