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Drug Eluting Stents Legal News Articles & Interviews

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Angioplasty TVAM, Doctors and the FDA

Angioplasty TVAM, Doctors and the FDA May 19, 2017. By Jane Mundy.
Washington, DC: Angioplasty was designed as a safe alternative to open heart surgery, but a procedure using balloon angioplasty devices called transvascular autonomic modulation (TVAM) is not safe, which the FDA has warned of repeatedly. Some doctors, however, believe its benefits outweigh the risks involved.
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FDA Warns Against Off Label Angioplasty Treatment Known as TVAM

FDA Warns Against Off Label Angioplasty Treatment Known as TVAM April 17, 2017. By Brenda Craig.
Dallas, TX The FDA is taking the unusual step of calling out a specific doctor and warning people to steer clear of the use of TVAM angioplasty as a treatment for serious illnesses such as Parkinson’s disease, Multiple Sclerosis and other autonomic disorders.
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Jury Still Out on Safety of Drug Eluting Stents

Jury Still Out on Safety of Drug Eluting Stents October 20, 2008. By Gordon Gibb.
Washington, DC When the US Food and Drug Administration (FDA) approved 'Endeavor,' the drug-coated Medtronic stent earlier this year, it did so amidst a storm of controversy as to whether or not the stents promote potentially dire blood clots in heart attack patients. Drug eluting stents are still under FDA scrutiny, but as 2008 dawned there was little conclusive evidence to prove the suspicion as fact.
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More Scrutiny of Stenting for Profit Industry

August 13, 2007. By Evelyn Pringle.
Washington, DC: The stenting for profit industry hit a major snag on March 1, 2007, when the US House Oversight and Government Reform Committee, ordered Johnson & Johnson and Boston Scientific to turn over documents related to their sales and marketing activities for drug-eluting stents.
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Feds Investigate Profits From Off-Label Stent Procedures - Part II

Feds Investigate Profits From Off-Label Stent Procedures - Part II May 25, 2007. By Evelyn Pringle.
Washington, DC: In addition to the federal investigations into the off-label marketing of drug eluting stents by Boston Scientific and Johnson & Johnson, on May 10, 2007, Rep Maurice Hinchey (D-NY), who serves on the House Appropriations Subcommittee, announced the introduction of the FDA reform bill which addresses the issue of doctors using products for unapproved uses, which usually occurs without the patient's knowledge or consent.
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Feds Investigate Profits From Off-Label Heart Stent Procedures - Part I

Feds Investigate Profits From Off-Label Heart Stent Procedures - Part I May 21, 2007. By Evelyn Pringle.
Washington DC The stenting for profit industry may soon be history. On March 1, 2007, the chairman of the US House Oversight and Government Reform Committee, Henry Waxman (D-CA), ordered Johnson & Johnson and Boston Scientific to turn over documents as part of an investigation into the off-label marketing of drug-eluting stents.
Read [ Feds Investigate Profits From Off-Label Heart Stent Procedures - Part I ]

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