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:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) announced ... Act of 1976, as amended ("HSR"), with respect to ... CPXX ) expired effective June 24, 2016, ... previously announced on May 31, 2016, Jazz Pharmaceuticals and ... Jazz Pharmaceuticals has commenced a tender offer for all ...
(Date:6/24/2016)... , June 24, 2016  Global Blood ... biopharmaceutical company developing novel therapeutics for the treatment ... today announced the closing of its previously announced ... stock, at the public offering price of $18.75 ... offering were offered by GBT. GBT estimates net ...
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World ... with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the ...
(Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are recognized ... this recognition are considered among the top 2 percent of lawyers practicing within the ... this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, Burt ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
Breaking Medicine News(10 mins):