Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), yesterday presented six-month data from the COMPLIANCE 360° study of severely calcified above-the-knee lesions at the 23rd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, sponsored by the Cardiovascular Research Foundation.

COMPLIANCE 360° is a prospective multi-center study which randomized treatment 1:1 with CSI’s Diamondback 360° against percutaneous transluminal angioplasty (PTA). Data demonstrated that, compared to PTA alone, orbital atherectomy with low-pressure PTA using CSI’s Diamondback 360° leads to better luminal gain by improving lesion compliance with less need for adjunctive stenting. Additionally, the Diamondback 360° arm required significantly less bailout stent replacement than the PTA arm.

Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., principal investigator of the COMPLIANCE 360° study noted, “The COMPLIANCE 360° study demonstrated that orbital atherectomy is superior to balloon angioplasty in its ability to achieve a good angiographic result with markedly decreased need for bailout stenting. At six months, patency in the orbital group was similar to the balloon group, despite stents used in just 5 percent of lesions in the orbital group versus 78 percent in the balloon group.”

Dr. Dattilo presented the following six-month data in an oral presentation:
    Diamondback 360° Arm   PTA Arm
<30% stenosis without bailout stent placement

92.1% of 38 lesions

21.4% of 28 lesions
Mean maximum balloon pressure

(p < 0.0001) (measure of lesions compliance)

 

3.97 atm

 

9.15 atm
Percent of patients free from TLR or restenosis at 6 months

72.7%
8.3%

COMPLIANCE 360° enrolled 50 patients (with 66 lesions) at 9 U.S. sites. Patients had calcified above-the-knee lesions greater than or equal to 70 percent, and were equally randomized to PTA alone versus therapy with the Diamondback 360°. Click here to read the full abstract.

David L. Martin, CSI president and chief executive officer, commented: “All of our data presented at the TCT conference reinforce the strength of CSI’s orbital technology in treating fibrotic and calcific lesions in both large and small vessels, as well as our commitment to clinical rigor and results. We now have treatment data from over 3,800 patients, 5,600 lesions and 500 physicians — more than any other device of its kind. This extensive data set demonstrates superb results with a 99.4 percent freedom from perforation, a 97.6 percent freedom from stenting and an 86.4 percent freedom from reintervention (at 24 months) in the peripheral arteries. CSI continues to lead the way in collecting scientific peripheral arterial disease (PAD) data to support physicians in their treatment decisions and ensure optimal outcomes for patients and their families.

“As longer-term data becomes available, we are excited to see durable outcomes demonstrating that our orbital systems — Stealth 360 °, Predator 360° and Diamondback 360° — provide safe, effective, durable treatment solutions for PAD anywhere in the leg. Additionally, we are pleased by the strong mid-term data from ORBIT I, our coronary feasibility study, which demonstrates 85 percent freedom from adverse events at 24 months in an extremely sick patient population. These patients would have been excluded from most other clinical studies due to the severity of their calcified lesions. We are excited about the possibility of treating this patient population as we continue to advance our ORBIT II study toward FDA clearance in treating severely calcified coronary lesions.”

ORBIT I was the initial feasibility study which enabled the ORBIT II trial to begin enrollment in the United States.

Coronary Arterial Disease Clinical Study Results

Two poster presentations by Dr. Keyur Parikh, Care Institute of Medical Science, Ahmedabad, India, analyzed data from ORBIT I, a feasibility study for a coronary application using CSI’s orbital mechanism of action. The prospective, multi-center, single-arm study enrolled 50 patients in India. Performing percutaneous coronary intervention (PCI) with varied coronary devices on calcified lesions can lead to adverse event rates as high as 24 percent at 30 days, perforation and other procedural issues. In Dr. Parikh’s studies:
  • Six-month, 50 patient follow-up data showed a low major adverse cardiac events (MACE) rate of 8 percent, demonstrating that the Diamondback 360° offers a new procedural method to debulk calcified coronary lesions and successfully facilitate stent delivery at the time of the procedure. Click here to read the full abstract.
  • Two-year data from a subset of 33 patients at a single center showed a MACE rate of 15.2 percent at two years. Click here to read the full abstract.

Peripheral Arterial Disease Clinical Study Results

Three additional studies highlighting the safety and efficacy of orbital atherectomy for treatment of peripheral arterial disease, or blockages in leg arteries, were presented during TCT poster sessions.
  • Six-Month Outcomes of Prospective, Randomized CALCIUM 360° Study Demonstrate the Advantages of Plaque Modification with the Orbital Technology Versus Treatment with Balloon Angioplasty in Patients with Critical Limb Ischemia, presented by Dr. Nicolas W. Shammas, Trinity Medical Center, Bettendorf, Iowa.CALCIUM 360° is a prospective, multi-center randomized study comparing treatment of below-the-knee lesions with the Diamondback 360° versus PTA. All 50 patients had critical limb ischemia (CLI) and calcified lesions. These conditions are challenging to treat in the small arteries below the knees and often a precursor to amputation.At six months, the Diamondback 360° provided superior outcomes:
    Diamondback 360º   Balloon Angioplasty
Bailout stenting 2 (6.7%) 4 (11.4%)
Final residual stenosis ≤30% without bailout stent 82.8% 61.8%
Deaths at six months 0 (0%) 3 (17.6%)
TLR/TVR at six months 0 (0%) 2 (11.8%)

Dr. Shammas noted, “CALCIUM 360° showed that the Diamondback 360° outperformed balloon angioplasty in calcified lesions by reducing major dissections and the need for stenting, both major limitations in treating CLI patients.” Click here to read the full abstract.
  • CONFIRM II Predator data, presented by Dr. Gaurav Aggarwala, Utah Cardiology, Layton, Utah.CONFIRM II Predator is a prospective registry of 1,127 patients treated with the Predator 360°, collected by 153 investigators at 122 institutions. The study is designed to determine device utility and procedural success in a real-world patient population. Device run time averaged 103 seconds per patient, followed, in a majority of lesions, by low-pressure angioplasty (mean 5.3 atms). Bailout stents were placed only in approximately 5 percent of lesions.Dr. Aggarwala commented, “The CONFIRM II study validates the use of orbital technology in restoring flow by changing lesions compliance, thus allowing low-pressure balloon angioplasty with limited complications and reduced need for bailout stenting.” Click here to read the full abstract.
  • Use of Orbital Treatment in a High-Volume Clinical Practice Modifies Non-Compliant Plaque to Deliver Durable Long-Term Results, presented by Dr. Prakash Makam, Community Hospital, Munster, Ind.Dr. Makam reported on a single-center study of 46 patients with fibrotic or calcified lesions who were treated with the Predator 360°. Average pre-treatment stenosis was 89 percent; in 84 percent of cases, low pressure balloon inflation was utilized to achieve a mean residual stenosis of 10.5 percent. No bailout stenting was required. Only five patients (10.9 percent) returned for retreatment of the target lesion within the 12-month follow-up period, validating previous long-term data reported in the OASIS LT trial. Click here to read the full abstract.

About Peripheral Arterial Disease

As many as 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) 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.

www.csi360.com

Millions of patients with PAD may benefit from treatment with the Stealth 360°, Predator 360°, or Diamondback 360⁰ devices, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to a guide wire, which sands away plaque while preserving healthy vessel tissue, or medial integrity — 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 CRF and TCT

The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies, drugs, and therapies in the subspecialty of interventional cardiology and endovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field. For more information, visit www.crf.org.

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 Stealth 360° TM, Diamondback 360 ® and Predator 360 ® PAD Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg 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 510(k) clearance for the use of the Diamondback 360° in August 2007, the Predator 360° in March 2009 and for the Stealth 360° in March 2011. To date, more than 55,000 PAD procedures have been performed using CSI's PAD systems in leading institutions across the United States.

CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.

For more information, visit the company’s website at www.csi360.com.

Product Disclosure

The Stealth 360° TM, Diamondback 360 ® and Predator 360 ® PAD Systems 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.

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