CSI at TCT 2011

CSI is leading the way in evidence-based medicine with consistent, predictable, repeatable results – acute and long-term –in small calcified arteries.

CSI's orbital technology has demonstrated:

• Changing lesion compliance in calcified lesions outperforms standard balloon angioplasty in peripheral arteries and allows for low-pressure balloon inflations.
• Consistently low-procedural complications in peripheral arteries which support the safety of our unique mechanism of action. In the peripheral arteries, safety of the procedure helps to reduce the need for amputations, saving the healthcare systems extra costs and keeping patients walking and remaining independent.
• Low bailout stent rates are consistently seen across all CSI studies. Preventing stent placement in the peripheral arteries supports current ACC/AHA treatment guidelines and keeps all treatment options intact for future reintervention, if necessary.
• A low target lesion revascularization rate at 12 months in the peripheral arteries.
• A low target lesion revascularization rates at 24 months in the ORBIT I trial.

SUMMARY OF ABSTRACTS PRESENTATED AT TCT ON CSI’s ORBITAL TECHNOLOGY

1. COMPLIANCE 360: 6-MONTH DATA – ORAL ABSTRACT

   Dr. Raymond Dattilo – St. Francis Medical Center, Topeka, KS

   Compared to PTA alone, orbital atherectomy with low-pressure PTA leads to better luminal gain by improving lesion compliance therefore significantly reducing the need for adjunctive stenting when treating calcified femopopliteal lesions. Target Lesion Revascularization (TLR) at 6 months for orbital atherectomy is comparable to the PTA randomization arm.

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2. CONFIRM II PREDATOR – POSTER PRESENTATION

   Dr. Gaurav Aggarwala – Utah Cardiology, Layton, UT

   The CONFIRM II Predator study validates the use of the solid crown iteration of orbital technology in restoring flow by changing lesion compliance. As demonstrated by this study, treatment of the peripheral arteries with the Predator 360⁰ device followed by low-pressure balloon angioplasty lead to low procedural complication rates (including a reduced need for bailout stenting). Orbital technology allows physicians to treat multiple arteries from hip to toes with just one device.

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3. CALCIUM 360: 6-MONTH DATA – POSTER PRESENTATION

   Dr. Nicolas Shammas – Midwest Cardiovascular Research Foundation, Davenport, IA

   CALCIUM 360 showed that orbital technology for treatment of severely calcified below-the-knee lesions lead to successful acute results. Target lesion revascularization (TLR) at 6 months with orbital technology demonstrated comparable durable results to balloon angioplasty.

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4. PREDATOR 360: 12-MONTH DATA – POSTER PRESENTATION

   Dr. Prakash Makam – Cardiovascular Research of Northwest Indiana, Munster, IN

   The use of orbital technology modified lesion compliance in resistant plaque throughout the leg as demonstrated by low-pressure balloon inflations and short duration balloon inflations post-orbital atherectomy. Bail-out stenting was eliminated in this challenging patient population, and use of orbital technology resulted in durable long-term results at 12-months with a low-reintervention rate of 10.9%.

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5. ORBIT I: 6-MONTH DATA – POSTER PRESENTATION

   Dr. Keyur Parikh – Care Institute of Medical Sciences, Ahmedabed, India

   The ORBIT I study demonstrates that orbital technology offers a new procedural method to debulk calcified coronary lesions and facilitate stent delivery at the time of the index procedure. The results remain positive out to 6 months post index procedure. A new, multi-center, prospective IDE trial (ORBIT II) is underway in the U.S. to obtain further data on the safety and effectiveness of orbital technology in severely calcified coronary lesions.

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6. ORBIT I: 24-MONTH DATA – POSTER PRESENTATION

   Dr. Keyur Parikh – Care Institute of Medical Sciences, Ahmedabed, India

   This single-center experience continued to follow ORBIT I patients out to 24 months post index procedure. The results demonstrate that the positive findings of using orbital technology to debulk calcified coronary lesions continued in this difficult to treat plaque morphology up to two years post index procedure.

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