10-28-13 8:00 AM EDT | Email Article

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), announced that Samin K. Sharma, M.D., Director of Clinical and Interventional Cardiology at The Mount Sinai Medical Center, New York, N.Y., is the first physician in the United States to treat severely calcified coronary lesions using the revolutionary, new Diamondback 360® Coronary Orbital Atherectomy System (OAS). The Diamondback 360 Coronary OAS uses a patented combination of differential sanding and centrifugal force to reduce arterial calcium that can cause complications when treating coronary artery disease (CAD). The system gained U.S. Food and Drug Administration (FDA) approval on October 21, 2013, and is the first and only technology approved for the treatment of severely calcified coronary lesions.

Cardiovascular Systems' revolutionary, new Diamondback 360(R) Coronary Orbital Atherectomy System wa ...

Cardiovascular Systems' revolutionary, new Diamondback 360(R) Coronary Orbital Atherectomy System was recently approved by the U.S. Food and Drug Administration to treat severely calcified lesions in coronary arteries. (Photo: Business Wire)

“Finally, there is a technology on the market to specifically address the challenge we face in treating severely calcified coronary lesions,” said Sharma. “The ease of performing orbital atherectomy with the Diamondback device should help to treat patients with severe coronary calcium that might have otherwise been overlooked due to the complexity of other technologies. I believe Orbital Atherectomy could potentially be used in at least 10 percent of PCI patients going forward.”

The Diamondback 360 Coronary OAS is an eccentrically mounted 1.25-millimeter diamond-coated crown that sands away calcium in coronary arteries, enabling stent deployment. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium.

Thirty-day data from CSI’s ORBIT II clinical study demonstrated that the Diamondback 360 Coronary OAS technology produced clinical outcomes that exceeded the trial’s two primary endpoints (safety and efficacy) by a significant margin. The 30-day freedom from major adverse cardiac events (MACE) rate was 89.6 percent and the primary effectiveness was 88.9 percent, including MACE. Furthermore, 97.7 percent of stents were successfully delivered and core lab assessed final procedure residual stenosis was 4.7 percent. The study included 443 patients at 49 U.S. medical centers and supported CSI’s Premarket Application (PMA) submission. ORBIT II was the first Investigational Device Exemption (IDE) study in history to support approval for treating severely calcified coronary lesions.

“CSI’s OAS technology is extremely promising, the unique orbital mechanism of action prepares the severely calcified coronary lesions for successful stent deployment,” said Sharma. “In addition to the impressive results of the ORBIT II study, data from the ORBIT I pilot study demonstrated positive results for the treatment of calcified coronary lesions.”

Approximately 16.3 million Americans suffer from Coronary Artery Disease (CAD). Arterial calcium is a common occurrence and can lead to significant complications. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention.

The Diamondback 360® Coronary OAS is approved by the FDA. For more information, please visit www.csi360.com or call 877-274-0901.

About Samin K. Sharma, MD

Samin K. Sharma, M.D., is the Director of Clinical and Interventional Cardiology at The Mount Sinai Medical Center. Sharma serves on the Cardiac Advisory Board of New York State for coronary interventions, which advises the health department and the governor on issues of health policies and supervision, safety and appropriateness of heart care by various hospitals in New York. In 2006, Sharma received the Governor's Award of Excellence for his outstanding contributions to medicine.

Sharma is widely published on topics of rotational atherectomy, newer interventional devices and drug eluting stents, as well as how to reduce various complications of coronary intervention by the use of beta-blockers and GP IIb/IIIa inhibitors and appropriate techniques for the interventional devices. He is especially interested in discovering ways to treat and reduce in-stent restenosis.

About the Mount Sinai Health System

The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven member hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 6,600 primary and specialty care physicians, 12-minority-owned free-standing ambulatory surgery centers, over 45 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island, as well as 31 affiliated community health centers. Physicians are affiliated with the Icahn School of Medicine at Mount Sinai, which is ranked among the top 20 medical schools both in National Institutes of Health funding and by U.S. News & World Report.

About Coronary Arterial Disease

Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a rapidly growing medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. To date, nearly 120,000 of CSI’s devices have been sold to leading institutions across the United States. The U.S. FDA granted approval for the use of the Diamondback 360® Coronary Orbital Atherectomy System on October 21, 2013. The 30-day data from CSI’s ORBIT II clinical study demonstrated that the Diamondback 360® Coronary OAS technology produced clinical outcomes that exceeded the trial’s two primary endpoints (safety and efficacy) by a significant margin. CSI is leading the industry with the Diamondback Revolution, a new movement providing innovative, evidence-based solutions that meet the demand for interventional cardiology treatments. For more information, visit the company’s website at www.csi360.com.

Product Disclosure

Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS is contraindicated when the ViperWire guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.

See the instructions for use before performing Diamondback 360 coronary orbital atherectomy procedures 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 this device to sale by or on the order of a physician.

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, the statement in this press release estimating that Orbital Atherectomy could potentially be used in at least 10% of PCI patients going forward is forward-looking statement.

These statements involve risks and uncertainties that could cause results to differ materially from those projected, including but not limited to the reluctance of physicians to accept new products; the effectiveness of the Diamondback 360 Coronary OAS; the impact of competitive products and pricing; approval of products for reimbursement and the level of reimbursement; 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.

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Morningstar - 2013/10/28 - Mount Sinai Cardiologist First in the United States to Use CSI’s Revolutionary New Technology to Treat Coronary Artery Disease
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