Navigation Links
Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to its Medical Devices
Date:12/29/2009

WASHINGTON, Dec. 29 /PRNewswire-USNewswire/ -- Spectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced today. The claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.

The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside the veins, including, specifically, the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.

In resolving this matter, Spectranetics has entered into a civil settlement agreement and a non-prosecution agreement with the United States. The company also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

According to the non-prosecution agreement, officers and employees who acted on behalf of the company engaged in multiple areas of wrongdoing. Specifically, Spectranetics illegally imported unapproved medical devices from overseas manufacturers and distributed those devices for use in human patients, and failed to meet its reporting obligations to FDA regarding a study named "CORAL" (COronary graft Results after Atherectomy with Lasers) and another associated study in connection with the devices listed above.

Under the terms of the non-prosecution agreement, Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation. As a result, Spectranetics will not be criminally prosecuted for this conduct. Under the civil settlement agreement, the United States asserted that, as a result of the conduct described here and set forth in more detail in the civil agreement, Spectranetics caused false claims to be submitted to the Medicare Program during portions of the time period from 2003 to 2008.

"It is important to hold those who submit false claims to Medicare responsible for their actions," said U.S. Attorney David Gaouette. "Settlements such as this help to protect the integrity of the Medicare system."

"The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers," said Tony West, Assistant Attorney General for the Justice Department's Civil Division.

"Our compliance agreement with Spectranetics holds the company and its executives accountable for violations of Federal health care program and FDA requirements," said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. "Records from Spectranetics' clinical investigations will be audited by an Independent Review Organization to ensure compliance with FDA rules - including reporting of adverse events."

The matter was handled by the U.S. Attorney's Office for the District of Colorado, the Office of Consumer Litigation and the Commercial Litigation Branch of the Justice Department's Civil Division and the Food and Drug Administration Office of Criminal Investigation. The corporate integrity agreement was handled by the Department of Health and Human Services Office of the Inspector General.

SOURCE U.S. Department of Justice


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Spectranetics Enrolls First Patient in PATENT Trial for the Treatment of Instent Restenosis
2. Genaera Corporation Presents Interim Phase 1 Data for Obesity Compound Trodusquemine (MSI-1436) at IBC Conference
3. CEL-SCI Corporation Releases Letter to Shareholders
4. Alfacell Corporation to Present at UBS Global Life Sciences Conference
5. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
6. Genaera Corporation Presents Preclinical Trodusquemine (MSI-1436) Data at the North American Association for the Study of Obesity Annual Meeting
7. Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting
8. The Quigley Corporation Reports Third Quarter Results, Increases Investment in Pharmaceutical R&D for Diabetic Neuropathy
9. Genaera Corporation Provides Highlights of Positive Phase 1 Trodusquemine (MSI-1436) Data from the North American Association for the Study of Obesity Annual Meeting
10. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
11. Immunosyn Corporation Releases SF-1019 Study Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... May 24, 2016 Een app ... zodat zij collectief patiënten kunnen behandelen, hun kennis kunnen ... idee achter de nieuwe en revolutionaire MDLinking App, ontwikkeld ... Nederlandse vaatchirurg dr. Hans Flu en oncologisch chirurg dr. ... inmiddels beschikbaar is, wordt op dinsdag 24 mei officieel ...
(Date:5/23/2016)... FLINT, Mich. , May 23, 2016 Diplomat ... the third annual Fellowship and Internship programs. The hands-on ... 12. The full-time, paid Fellowship ... Flint, Michigan . Fellows and interns are ... downtown Flint at the Riverfront ...
(Date:5/23/2016)... , May 23, 2016 ... Devices, Diagnostics and Monitoring, and Vision Care ... Which areas are going to grow at the fastest ... revenues to 2026, assessing data, trends, opportunities and prospects. ... charts, and graphs. Discover the most lucrative areas in ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... 25, 2016 , ... Casa Velas, an adults-only boutique hotel in Puerto Vallarta, ... its new wellness suites . The two 1,350 sq. ft. suites which debuted ... services and insuite amenities, from a custom soap selection and in-suite exercise kit to ...
(Date:5/25/2016)... , ... May 25, 2016 , ... America Walks ... Carol Reichbaum, M.S.L., M.S.P.A., of the University of Pittsburgh Graduate School of Public ... will enable Ms. Reichbaum and 24 other advocates from around the country to participate ...
(Date:5/25/2016)... ... May 25, 2016 , ... "FCPX LUT Intense allows ... your footage," said Christina Austin - CEO of Pixel Film Studios. , With ... and easily add stylish color grades to their footage. A LUT is a Lookup ...
(Date:5/25/2016)... ... May 25, 2016 , ... Consumer access to organic foods ... 2016, Kashi®, a maker of whole grain cereals and other plant-based foods, will introduce ... hard red winter wheat processed by Hesco/Dakota Organic Products. , The transitional designation ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... Stern ... firm will be selling the device branded as Stern’s Real Time Monitoring ... to bedbugs to the hotel and motel industry, colleges for use in dormitories, shelters, ...
Breaking Medicine News(10 mins):