Company Announcements

Cardiovascular Systems, Inc. Announces First Uses of WIRION® Embolic Protection System

Device offers a streamlined approach for lower extremity embolic protection

ST. PAUL, Minn.--(BUSINESS WIRE)--Mar. 17, 2021-- 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 first patients in the U.S. have been treated with the WIRION® Embolic Protection System.

WIRION is a distal embolic protection filter used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy. Physicians typically use embolic protection devices in vessels located above the knee with long lesions, high plaque burden and poor run off.

Dr. Lawrence Garcia, St. Elizabeth’s Medical Center, Boston, Mass. and Dr. Nicolas Shammas, Unity Point Health-Trinity Bettendorf, Davenport, Iowa participated in the WISE LE study where WIRION demonstrated a major adverse event (MAE) rate of 1.9%, which is lower than previously reported rates for other lower extremity embolic protection filters. Importantly, no clinically significant distal embolization was observed when WIRION was used.

Said Dr. Garcia, “WIRION represents a critical advancement for distal embolic protection devices. With WIRION, I can use my preferred 0.014” guidewire to cross the lesion and then place the filter anywhere on the wire. As a result, I am able to provide extensive support, individualized to each patient and intervention.”

Said Dr. Shammas, “Delivery and retrieval of WIRION are easy with a minimal learning curve. Debris capture is very efficient making WIRION exceptionally suited for use with any atherectomy device.”

Scott R. Ward, CSI Chairman, President and Chief Executive Officer, said, “We are excited to announce the commercialization of WIRION. This product will be an important part of our comprehensive portfolio of differentiated products designed to save limbs and improve outcomes for patients undergoing complex peripheral interventions.”

About WISE LE

WISE LE (WIRION EPS in Lower Extremities Arteries) was a multicenter study, performed in the United States and Germany and included all commercially-available atherectomy systems. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization.

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.

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 WIRION system; the commercialization of the WIRION system; and CSI’s 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 the WIRION system; 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: WIRION is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION may be used with commercially available 0.014" guide wires.

Contraindications: The system is contraindicated for patients with severe allergy to Heparin, patients with uncorrected bleeding disorder, and patients in whom anticoagulant and antiplatelet therapy is contraindicated.

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

The WIRION® Embolic Protection System received FDA clearance and CE Mark approval in March 2021.

Cardiovascular Systems, Inc.
Jack Nielsen
Vice President, Investor Relations & Corporate Communications
(651) 202-4919
j.nielsen@csi360.com

Source: Cardiovascular Systems, Inc.