Vascular Device Forum

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

Diamondback Orbital Atherectomy System-CardiovascularSystemsInc

Below is the press release from Cardiovascular Systems Inc regarding its orbital atherectomy system:

New Device for Clearing Blocked Arteries in the Legs Receives FDA Clearance for Peripheral Use — Procedures Performed Across the US Within First 48 Hours. | September 25, 2007

Minneapolis, MN - Cardiovascular Systems, Inc. (CSI) announced today that the U.S. Food and Drug Administration (FDA) has cleared the use of the Diamondback 360° ™Orbital Atherectomy System(OAS) for removing plaque blockages in the legs (peripherals) and restoring blood flow. The device offers a promising new alternative for treating complex diffuse disease for patients suffering from Peripheral Arterial Disease PAD.

The clearance follows the successful completion of a rigorous clinical study involving 124 patients, which demonstrated dramatic plaque reduction in leg arteries with lasting results. The OASIS trial exceeded the FDA’s Objective Performance Criteria (OPC) on multiple key measurable endpoints including the amount of plaque reduced, percentage of patients that did not require repeat procedures, and the overall safety and efficacy of the device. According to Dr. Daniel Dulas of Mercy Hospital and one of the physicians involved in the trial, "these results represent what I believe Is a giant step forward in the treatment and care of patients with diffuse vascular disease." "" The device differs from existing atherectomy technologies in its ability to remove hard, calcified plaque– in addition to other common kinds of plaque — using a unique "orbiting" action. A tiny, diamond-coated crown uses the principles of centrifugal force to rapidly spin or "orbit" at high speeds and sand away plaque, while preserving the healthy tissue of the arterial wall. According to Dr. P.K. Khanna of Eisenhower Hospital, "The resulting particles are about 75% smaller than red blood cells, which eliminates the need for a distal embolization protection device." Existing devices have rarely been able to penetrate and effectively remove the "brick wall" of calcium, which has limited physicians' ability to treat a vast subset of patients.

Within 48 hours of clearance, major medical centers across the country began adopting the new technology. The first doctors successfully completing procedures included Lou Lopez MD, St. Joseph Hospital, IN; Tom Davis MD, Detroit Medical Center, MI; Khusrow Niazi MD, Emory Crawford Long Hospital, GA; P.K. Khanna MD, Eisenhower Hospital, CA; and Daniel Dulas MD, Mercy Medical Center, MN. Dr. Tom Davis of Detroit Medical Center explains, "up until now, we have not had an effective tool for treating heavily calcified vessels . . . this technology is a significant breakthrough for treating PAD. The Diamondback 360° allows me the ability to offer my patients almost instantaneous improvement in restoring mobility and/or healing wounds." Dozens of patients were treated successfully within the first couple of weeks of release.

Over 12 million people in the US alone suffer from PAD; a life-threatening condition where plaque builds up on the inside walls of the blood vessels. This build-up causes the arteries to harden and narrow — a condition known as atherosclerosis — reducing blood flow to the legs and feet. If allowed to progress, PAD can cause debilitating pain and possibly lead to Critical Limb Ischemia (CLI), which may result in non-healing wounds and eventual amputation.

The Diamondback 360° Orbital Atherectomy System is designed to optimize the ability to remove peripheral arterial blockages, restore quality of life and save limbs. It is protected by 22 U.S. patents with additional patents pending. CSI company history, management and clinical information are available at www.csi360.com.

Forward-Looking Statements: Certain statements contained in this press release and other written and oral statements made from time to time by the Company do not relate strictly to historical or current facts. As such, they are considered forward-looking statements which provide current expectations or forecasts of future events. The statements in this press release regarding (i) Dr. Dulas’s belief that the Oasis clinical trial results represent a new standard of care; and (ii) Dr. Davis’s statement that the technology represents a breakthrough for treating PAD, are forward looking statements. These statements involve a variety of risks and uncertainties, known and unknown, including, among others, the risks that (i) the Company's Diamondback 360° Orbital Atherectomy System will not receive wide acceptance by physicians, (ii) the Company may encounter problems in the manufacturing or distribution of the Diamondback 360° Orbital Atherectomy System that prevent the Company from achieving anticipated growth, and (iii) physicians do not achieve satisfactory results from treating patients with the Orbital Atherectomy System. Consequently, no forward-looking statement can be guaranteed and actual results may vary materially from those anticipated in such forward looking statements.

John Simpson Foxhollow CEO, Serial Entrepreneur

The following contains exerpts from an article in In Vivo Business and Medical report in April of 2003. Its an interview with John Simpson MD, MPH, current CEO of Foxhollow Technology, a prolific medical device entrepreneur. His name is mentioned in the same conversation as Dr Fogarty. It's highlighted by several interesting points

1) Dr Simpson never set out to be a physician and still does not consider himself a businessman despite having a half dozen successful medical device companies under his belt.

2) He still focuses on what he believes to be the most critical component to driving medical device innovation: The Patient

3) He is best known for development of over the wire angioplasty through his first company, ACS. He followed that with companies involved with ultrasound (CVIS), Atherectomy (DVI and Foxhollow), vascular closure (Perclose)and chronic total occlusion (Lumend)

Read the rest of this article from 2003....

EV3 and Foxhollow Company Mergery-Why?

On July 22, 2007 EV3 and Foxhollow Technology announced completion of an agreement for merger which had long been considered under discussions. The discussions were long rumored to have been taking place. There were some obvious synergies between the companies. There were rumors that  EV3's Spider AntiEmbolic Device (AED) would be packaged with the Foxhollow Plaque Excision device.

One of the known complications of the atherectomy procedure is peripheral embolization. In the TALON study, the incidence of embolization was approximately .1-.2%. My anectdotal experience is that the incidence of atheroembolism is higher. Its is suggested that failure to repack frequently and excessively rapid advancement of the device is the cause of embolism.

I think that it is likely that the incidence of embolization could potentially be higher in the early learning curve phase of device usage. I had a short conversation with an early user/consultant of the company who suggested that he has never seen embolization. Personally, I question the recollection of this interventionalist.

Another experienced early user wrote the following:

How Distal Anti-Embolic Interventions Can Aid Patients
The emergence of distal protection devices (DPD) has raised concerns about the incidence of distal embolization (DE) during all of our vascular interventions.^21-22 Distal macro- and microembolization can be particularly catastrophic in the CLI patient with poor and oftentimes only a single, vessel runoff. The Spider FX (ev3, Inc.) is a user-friendly DPD system designed primarily for coronary and carotid artery stenting but it is now seeing expanded use with CLI. Vascular interventionalists can position the fine mesh net filter system before intervention in distal vessels between 3 and 7 mm, and allow capture and removal of macro- and microembolic debris as small as 100 microns created during the intervention.
       This DPD strategy has allowed vascular surgeons to perform more aggressive plaque debulking and interventional strategies with less risk of distal embolic injury to the already compromised downstream microcirculation. Distal protection devices have become mandatory during carotid stenting and are common in complex coronary interventions. I now utilize a DPD in the majority of my CLI interventions. In my opinion, it allows even more aggressive revascularization and facilitates improved outcomes. I predict widespread adoption of this DPD strategy in treating CLI.

       Dr. Allie is the Chief of Cardiothoracic and Endovascular Surgery at the Cardiovascular Institute of the South in Lafayette, La.

Im looking for some commentary on the experience of users with Silverhawk and atherectomy. Distal protection or not. Selective; under what circumstances. What device would you use?

SilverHawk Atherectomy Plaque Excision-Proponents Viewpoint