http://www.yourlawyer.com/topics/overview/boston_scientific_express_stent Sat, 21 Nov 2009 02:52:32 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16753 Thu, 16 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16753 Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas.   According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.

Allegations of kickbacks by medical device makers are nothing new.  For example, in 2007 a New Jersey based federal probe found  that some orthopedic device makers made lucrative payments to U.S. physicians  between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The lawsuits detailed by The Wall Street Journal, which were filed in federal court in Houston, are related to an inquiry in Texas by the U.S. Justice Department that was previously disclosed by several of the companies in filings with the Securities and Exchange Commission.  They were originally filed in 2007, the Journal said.

According to the Journal, the lawsuits allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program.  For example, several of the suits allege that Boston Scientific, Medtronic and AtriCure marketed surgical ablation equipment as a treatment for atrial fibrillation even though it was not approved by the Food and Drug Administration to treat that condition.

Those charges were made by a former Boston Scientific salesperson, who the Journal says, claimed to have been fired after complaining about the company's allegedly illegal practices.

All of the companies involved in the lawsuits told The Wall Street Journal that they were cooperating with the probe.  Boston Scientific is no longer in the ablation business, the Journal said.

]]> http://www.yourlawyer.com/articles/read/12294 Wed, 29 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12294
In fact, the Ohio-based center said patients implanted with the drug-coated devices designed to prevent re-closing of the coronary artery, a condition known as restenosis may have as much as a four- to five-fold greater risk for late thrombosis, or blood-clot formation, compared to patients implanted with the earlier generation, bare-metal stents.

"Our analysis found there is a small, but real, hazard of late stent thrombosis with drug-eluting stents more so than with bare-metal stents, likely in the setting of discontinuation of anti-clotting drugs," said Deepak Bhatt, associate director of the Cleveland Clinic's Cardiovascular Coordinating Center and one of the study's authors.

"This does not, however, mean that drug-eluting stents should not be used, as other studies have shown that they do significantly reduce the need for repeat procedures compared with bare-metal stents."

The meta-analysis focused on 14 studies involving 6,675 patients who had been implanted either with a sirolimus-coated or a paclitaxel-coated stent. Eight of those studies reported more than a year of clinical follow-up.

The patients with sirolimus-coated stents took anti-clotting medication for at least two to three months post-implantation, while the patients with paclitaxel-coated stents took clot-busting drugs for six months.

"The key to the controversy is likely careful patient selection," Bhatt said. "Further research is needed to determine how best to utilize drug-eluting stents and anti-clotting medications."

The study appears in the December issue of the American Journal of Medicine.]]> http://www.yourlawyer.com/articles/read/12121 Fri, 08 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12121
The medical device maker reported the finding of its own new study to the U.S. Food and Drug Administration shortly after completing an analysis in late June, and met with the agency Aug. 1 to discuss the finding, company spokesman Paul Donovan said.

The Natick, Mass. based company reviewed previous clinical data involving 3,500 patients to compare rates of clotting in patients with its Taxus stent compared with older stents that are not coated with drugs.

The drug coatings are intended to help prevent formation of scar tissue that can form new blockages after surgery to implant stents, which are metal-mesh tubes that prop open coronary arteries. But recent studies, including findings released Sunday at the World Cardiology Congress in Barcelona, Spain, have indicated drug-coated stents carry a higher risk of rare instances of potentially fatal blood clots.

Boston Scientific's review confirmed that a higher risk exists in Taxus, the company's top-selling product and one of just two drug-coated stents on the U.S. market. While the stents are often credited with helping prevent heart attacks and bypass surgery, the review found a statistically significant higher rate of so-called "late stent thrombosis," or clotting, with Taxus in a period beginning six months after surgery compared with bare-metal stents.

"We have seen a slight increase in late stent thrombosis, which a number of studies have clearly shown to be a class effect common to drug-eluting stents," Donovan said. "The important point is we have seen no increases in heart at tacks or deaths."

Nearly 6 million people worldwide now have the drug-lined ver sions from the two dominant drug- coated stent makers, Boston Scientific and Johnson & Johnson's Miami Lakes, Fla.-based Cordis unit.

New Brunswick-based J&J has said it sees no statistically significant risk of late thrombosis in Cy pher.

Some of the blood-clotting concern stems from the fact that bare- metal stents allow heart cells to naturally grow to cover the stent after surgery, providing a natural biological lining. Drug-coated ver sions can prevent tissue growth, which helps prevent blockages but apparently leaves exposed metal that can act as a clot magnet.
]]> http://www.yourlawyer.com/articles/read/8254 Fri, 23 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8254
Reason for Recall: Characteristics in the design of this stent system resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement.

Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Hospitals should immediately discontinue use of any affected units. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.]]> http://www.yourlawyer.com/articles/read/6906 Mon, 03 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6906
FDA has received more than 290 reports of thrombosis (clotting) occurring one to 30 days after the procedure to implant the device. In more than 60 of these reports, use of the device was associated with the death of the patient; in the remainder, the device was associated with injury requiring medical or surgical intervention.

FDA has also received more than 50 reports, including some deaths, that Cordis considers to be possible hypersensitivity reactions. The symptoms include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.

Hundreds of thousands of patients have been successfully treated with the Cypher stent. FDA does not have enough information to determine whether the incidents of thrombosis and hypersensitivity reaction with the Cypher stent differs from those experienced with bare metal stents.

FDA approved the Cypher stent in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. The stent, a cylindrical metal mesh, is designed to keep the arteries from re-clogging after the procedure. It is coated with a thin polymer containing the drug sirolimus that is slowly released into the patient and is intended to reduce the rate of re-blockage that occurs with other stents.

The cause of these adverse events has not yet been determined. FDA and Cordis are working quickly to gather as much information as possible about the circumstances surrounding these events. FDA is also working with the regulatory bodies of other countries to get more information about foreign experience with the Cypher stent.

Until FDA gets to the root of the problems, the agency is encouraging doctors to follow the instructions for use of the stent, and urging them to be vigilant for any patient symptom that may be attributed to hypersensitivity.

Patients who have received this stent should continue to follow their regularly scheduled plan for follow-up appointments with their doctor.

As a condition of approval, FDA is requiring Cordis to conduct a 2000-patient post-approval study and continue evaluating patients from ongoing clinical trials to assess the long-term safety and effectiveness of the stent and to look for rare adverse events that may result from use of the product.

Doctors and patients who have experienced an adverse event related to the stent are encouraged to report the incident to the FDA]]> http://www.yourlawyer.com/topics/overview/boston_scientific_express_stent Mon, 03 Nov 2003 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/boston_scientific_express_stent Boston Scientific Express Stent The FDA has recalled Boston Scientific Express2TM (bare metal) coronary stents. The Express2™ stent system consists of a stent (small metal tube) which is mounted on a balloon catheter. The stent is inserted into a blood vessel and advanced within the vessel to the narrowed section of the coronary artery.

When the stent is correctly positioned, the balloon is inflated, causing the stent to expand. Expansion of the stent pushes the plaque aside, opening the narrowed section of the artery restoring normal blow flow to the heart. The balloon on the stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The stent remains permanently implanted supporting the newly opened section of the vessel.

The FDA recalled the stents because of characteristics in the design of the stent system caused failure of the balloon to deflate and impeded removal of the balloon after stent placement. Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Hospitals should immediately discontinue use of any affected units.

Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.

If you or a loved one suffered injuries from a Boston Scientific Express stent, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>