WIRION Embolic Protection System – 1st Patients Treated Reports Cardiovascular Systems, Inc.

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WIRION Embolic Protection System 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 runoff.

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.”

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.

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.

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