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 a
'/>"/>

SOURCE U.S. Department of Justice
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:7/21/2014)... , July 21, 2014 Thoratec Corporation ... device-based mechanical circulatory support therapies to save, support and ... its operating results for the second quarter of fiscal ... company will hold a conference call to discuss its ... parties, at 1:30 p.m., Pacific Daylight Time (4:30 p.m., ...
(Date:7/21/2014)... 2014  EHE International, the recognized leader in preventive ... network, today announced that Dignity Health Medical Group Nevada, ... has been named an EHE-certified preventive care center. Through ... region now have greater access to EHE,s ... "EHE is proud to add Dignity ...
(Date:7/21/2014)... , July 21, 2014 /PRNewswire-iReach/ -- Top ... GPM Pediatrics responds to an article, which suggests that ... Logo - http://photos.prnewswire.com/prnh/20140718/128611 ... about giving coffee to children, but now it happens ... . A new study, published in the journal Pediatrics, ...
Breaking Medicine Technology:Thoratec Schedules Second Quarter Conference Call, Webcast 2EHE International Certifies Dignity Health Medical Group Nevada, LLC as Its Newest Partner 2Dr. Michael Gabriel a Brooklyn Pediatrician Comments on an Article, Which Suggests Caffeine May Be Dangerous for Children 2
... Leading orthopaedic surgeon Simon Moyes has launched a ... from the surgeon,s viewpoint and from inside the joint. ... kind, has been developed by Simon Moyes along ... devices, and is aimed at students, junior surgeons and patients ...
... Jan. 11, 2012  SuccessEHS announces that its newest release ... times when compared to previous releases.  The company has ... Record (EHR) and Practice Management software solution ... The upcoming release will focus on user efficiency and ...
Cached Medicine Technology:Simon Moyes Pioneers New Keyhole Surgery Website 2Newest SuccessEHS Release to Increase Physician Software Usability 2Newest SuccessEHS Release to Increase Physician Software Usability 3
(Date:7/22/2014)... 2014) With over 170,000 students now playing ... to injuries during practice and competition, according to a ... and the Center for Injury Research and Policy at ... published online today by The American Journal of ... experienced 1,406 injuries over the four academic years from ...
(Date:7/22/2014)... Garland’s new Energizer BK specially formulated cold-applied ... flood coat over new and existing asphalt and coal ... It provides natural resistance to moisture, chemicals, UV and ... Energizer BK is specially formulated with an asphalt coal ... to superior strength and flexibility. , The cold-applied ...
(Date:7/22/2014)... July 22, 2014 CareTouch Communications, Inc. ... CareTouch in the Community . CareTouch employees will select ... provide hands-on support in line with their mission to ... health. The program’s first cause is Hike for Hospice, ... , On Sunday, September 14, the CareTouch in the ...
(Date:7/22/2014)... 2014 Most people encounter the same two problems ... and the second is a fast metabolism. These are hard problems ... provides ways to help fight these problems and to finally gain ... people out there who just can’t seem to eat more than ... are full. The cause of this problem can vary. For some ...
(Date:7/22/2014)... (PRWEB) July 22, 2014 A new ... address skin laxity with results that are surprising even ... topically treating the skin with radio frequency, ThermiTight has ... are inserted under the skin to “inject” heat to ... shown that this single treatment solution for skin laxity ...
Breaking Medicine News(10 mins):Health News:High school lacrosse players at risk of concussions other injuries 2Health News:High school lacrosse players at risk of concussions other injuries 3Health News:Energizer® BK Waterproof Coating from Garland Canada Reduces Life-Cycle Costs 2Health News:CareTouch is a Peak Sponsor for the 9th Annual Hike for Hospice in Morrison, Colorado 2Health News:CB-1 Weight Gainer Provides Two Tips to Help Customers Gain Weight 2Health News:New Minimally Invasive Procedure, ThermiTight, “Injects” Radio Frequency to Treat Skin Laxity 2
... have contained the spread of the bird flu successfully, scientists ... presence// of a live chain of the disease. ,Researchers ... many of the samples are unfit for testing as proper ... ,"Most bird flu samples reaching us remain unfit for ...
... first pregnancy after 30 are vulnerable to heart attacks, ... more vulnerable because of hardening of their arteries and ... pregnancy, said researchers at Duke Medical Centre in North ... 12 million pregnant women and found that heart attacks ...
... Europe, reports a league table, to be published before this ... the treatment and encourages childless women to take part in ... , When compared to the success rates of fertility ... attain a success rate of 28.6%. this is a very ...
... promotes body growth, is produced in the brain according to ... The researchers have been able to trace the origin of ... brain in charge of memory and emotion – called the ... fact that more growth hormones are produced in females than ...
... years may see the development of a new contraceptive pill ... It also has the added benefit of eliminating periods. // ... around the world is a combination of estrogen and progesterone. ... problems such as deep vein thrombosis. ,Another, progesterone ...
... drinkers and men are prone to higher incidences of colon ... // University in Evanston said that the factors mentioned have ... the key to determining the ideal screening method to be ... colorectal cancer, that showed alcohol and tobacco users were open ...
Cached Medicine News:Health News:Presence Of Live Avian Flu Is A Cause Of Concern: Scientists 2Health News:British fertility clinics have low success rates 2Health News:Revolutionary Pill Cuts Risk of Breast Cancer 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: