CSI Orbital Atherectomy-A Challenge to Foxhollow's Silverhawk

Cadiovascular Systems Incorporated (CSI) Inc lead by CEO David Martin who is former COO of Foxhollowtech in 2004 IPO. He has a proven track record of guiding private companies through the IPO process. CSI presents the first significant challenge to the heretofore barren landscape of atherectomy occupied soley by FoxhollowTech and Silverhawk.

The FDA approval is based largely upon the Orbital Atherectomy System Investigational Study (OASIS) trial. 124 patients were treated in the Diamondback 360 Orbital Atherectomy System. The trial evaluated efficacy, safety and target lesion revascularization (TLR) at 30 and 180 days.

Diamondback 360°           ViperWire™ Guide Wire            ViperWire™ Guide Wire Controller

• Ergonomic design with flat surface for table stability
• Lightweight
• Ergonomic control knob for maximum tactile feedback

Controller Diamondback 360°

• Specifically designed for the Diamondback 360° System to achieve maximum performance
• Available in intermediate and firm

• Touch-screen interface on easily maneuverable, lightweight IV pole
• Ergonomic design with flat surface for table stability
• Lightweight
• Ergonomic control knob for maximum tactile feedback

Diamondback 360°           ViperWire™ Guide Wire Controller

• Ergonomic design with flat surface for table stability
• Lightweight
• Ergonomic control k
• nob for maximum tactile feedback

• Specifically designed for the Diamondback 360° System to achieve maximum performance
• Available in intermediate and firm

• Touch-screen interface on easily maneuverable, lightweight IV pole

• Specifically designed for the Diamondback 360° System to achieve maximum performance
• Available in intermediate and firm

• Touch-screen interface on easily maneuverable, lightweight IV pole

OASIS: a prospective, multi-center, IDE clinical study, was conducted to evaluate the efficacy and safety of the Diamondback 360° System. In 124 patients with 201 lesions, results met or exceeded FDA Objective Performance Criteria (OPC) targets.*
Preliminary 6 month follow-up data OPC Target OASIS Result Non-Inferiority P-Value Primary efficacy endpoint Acute debulking measured angiographically 55% reduction 62% reduction p<0.0001 Primary safety endpoint Cumulative number of patients with serious adverse events through 30 days 16% SAE’s 8% SAE’s 4% Device Related p<0.05 Secondary efficacy/safety endpoint TLR rate through 6 months 20%TLR 0.9%TLR p<0.00001, power = 0.99
119 out of 124 patients treated at 30 day endpoint had no device related SAE’s 2 minor perforations (1 distal to treated area following angioplasty) 1 distal embolization * OASIS Clinical Study – CSI 2006 (Orbital Atherectomy System for the Treatment of Peripheral Vascular Stenosis) The Diamondback 360° Orbital Atherectomy System currently has a pending 510(k) for use in the treatment of peripheral artery stenosis. For more information about the new Diamondback 360°™ Orbital Atherectomy System from CSI, please contact your local CSI representative or call customer service at 877.CSI.0360

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Cadiovascular Systems Incorporated (CSI) Inc lead by CEO David Martin who is former COO of Foxhollowtech in 2004 IPO. He has a proven track record of guiding private companies through the IPO process. CSI presents the first significant challenge to...