Cardiovascular Systems, Inc. Announces First Patients Treated from Radial Access Using Its Diamondback 360 Extended Length Peripheral Orbital Atherectomy Device

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI^®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for peripheral and coronary artery disease, announced today that the first patients were treated using its FDA-cleared extended length Diamondback 360^® Peripheral Orbital Atherectomy Device (OAD) to treat peripheral artery disease (PAD). Dr. Mahir Elder, an interventional cardiologist at the Detroit Medical Center Heart Hospital, and Drs. Ian Cawich and Vasili Lendel, both interventional cardiologists at Arkansas Heart Hospital, treated patients using the new device.

Dr. Cawich noted, “From a physician’s perspective, radial access is a viable alternative that allows us to minimize bleeding and avoid commonly diseased femoral arteries. Additionally, it allows for both bilateral diagnostics and interventions while also eliminating the need for femoral closure devices. The result for patients is a far less invasive procedure.”

Scott Ward, CSI Chairman, President, and Chief Executive Officer, said “The first procedures using the extended length Diamondback 360 OAD is a milestone for physicians, patients, and our company. When surgery is necessary, PAD lesions can be treated through femoral artery access. However, factors such as obesity, the presence of vascular disease and scar tissue can complicate femoral access. Radial access allows physicians to reach and treat lower limb PAD lesions through the radial artery in the wrist, providing an alternative access point and more options to treat complicated and at-risk patients.”

Dr. Lendel added, “Radial access has been on the rise for percutaneous coronary interventions for several years, and the benefits have been well documented. Now, I’m excited that new devices like CSI’s Extended Length OAS are enabling me to bring the benefits of radial access to another patient population in those undergoing peripheral vascular interventions.”

Patient and Physician Benefits
As an alternative to femoral access, the extended length Diamondback 360 OAD reduces invasiveness, and often results in greater patient satisfaction. In addition, patients experience:

• Fewer access site bleeding complications;
• The ability to walk less than an hour post-procedure; and
• Shorter hospital stays, on average.

Said Dr. Elder, “As an interventional cardiologist, I value the ability to treat my PAD patients with this device. Treating PAD via radial access enables me to provide a better patient experience that includes faster ambulation and discharge than treating via femoral access.”

Radial Access Diamondback 360 OAD Availability
The radial access Diamondback 360 OAD, currently available via a limited market rollout, features a 5 Fr profile and three crown sizes:

• 1.25 diameter solid, 200 cm length
• 1.50 diameter solid, 200 cm length
• 1.75 diameter solid, 180 cm length

CSI anticipates a full commercial launch of the device in its fiscal year 2019.

Concluded Ward, “CSI is committed to innovation and cultivating less invasive access sites for percutaneous interventions. Our extended length Diamondback 360 OAD demonstrates that commitment and reflects the hard work of our team on behalf of patients and physicians.”

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 Systems treat calcified and fibrotic 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. The U.S. FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 356,000 of CSI’s devices have been sold to leading institutions across the United States. For more information, visit the company’s website at www.csi360.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 the extended length Diamondback 360 OAD and the full commercial launch thereof, including the anticipated timing of such launch, 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; 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.

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. Literature shows that Balloon angioplasty and stents can 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. Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Diamondback 360^® and Stealth 360^® Peripheral Orbital Atherectomy Systems, which are 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.

Product Disclosure:

Peripheral Products
The Stealth 360^® PAD System and Diamondback 360^® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated 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. 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.

 

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