The Department of Justice (DoJ) has charged Guidant, a wholly-owned subsidiary of Boston Scientific, with covering-up device failure problems associated with its Ventak Prizm 2 DR and Contak Renewal implantable cardioverter-defibrillators (ICD).
Boston Scientific is not closing international headquarters in Paris and Tokyo, as we incorrectly reported last week. It is eliminating its Natick, Mass.-based International headquarters. The corrected article can be read here. We apologize for any confusion.
Boston Scientific has begun to restructure its leadership team and modify the organization--including significant changes to its international headquarters in Natick, Mass.--and initiated layoffs of 8 to 10 percent of its non-direct labor base.
Boston Scientific has settled three patent disputes with Johnson & Johnson (J&J) for $1.73 billion.
A budding whistleblower suit made public Monday exposed allegations that Boston Scientific, Abbott Laboratories and Cordis fraudulently marketed and promoted biliary stents for vascular use—an action not approved by the FDA.
The everolimus-eluting stent is better than the second-generation paclitaxel-eluting stent (Taxus Liberte, Boston Scientific) in unselected patients undergoing PCI in terms of safety and efficacy, concluded the COMPARE trial that was published Jan. 7 in Lancet. Based on these findings, the authors suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice.
Orlando, Fla.—The addition of clopidogrel to aspirin did not lead to a significant reduction in vein graft intimal hyperplasia during the first year after CABG, according to the CASCADE trial presented Monday during the late-breaking clinical trials session at the 2009 American Heart Association conference.
AtriCure, a developer of cardiac surgical ablation systems, has reached a tentative settlement agreement with the Department of Justice (DoJ) in a qui tam case filed in 2007 for $3.8 million plus interest over a five-year period.
Due to stronger sales, Boston Scientific has booked large (unaudited) net gains in the 2009 third quarter, which ended Sept. 30.
The Harvard Clinical Research Institute (HCRI) has reported that the first patients have been enrolled in the DAPT [dual-antiplatelet therapy] Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual-antiplatelet therapy following drug-eluting stent (DES) implantations.
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Written by Justine Cadet
As clinical trial data have shifted toward favoring second-generation drug-eluting stents (DES), the market has trended in a similar direction. In addition, the overall positive results with most DES have emboldened physicians to use them for more complex disease states, including left main disease—to the dismay and excitement of many.
Boston Scientific has financial results for the fourth quarter and full year, which ended Dec. 31, 2009, indicating a reduction in net losses for both.
Boston Scientific has rebutted a case study, published Feb. 13 in Heart Rhythm, which claimed there was inappropriate shock from an uncommon cause of non-physiologic noise during a subcutaneously implantation of the company’s Cognis N119 cardiac resynchronization therapy defibrillator (CRT-D).
Boston Scientific presented new versions of its ablation and diagnostic catheters at the 15th annual Boston Atrial Fibrillation Symposium last week.
Boston Scientific's Promus and Abbott's Xience V, two everolimus-eluting coronary stent systems used to treat coronary artery disease, have received approval from the Japanese Ministry of Health, Labor and Welfare for marketing and distribution rights throughout Japan.
While implantable cardioverter-defibrillators (ICDs) have been known to reduce mortality rates in patients, an analysis of four manufactured devices published in the December edition of the Heart Rhythm Journal found that upgrades to these devices are needed in order to further improve patient care.
Boston Scientific has reached an agreement in principle with the U.S. Department of Justice (DoJ) related to product advisories issued by its Guidant subsidiary in 2005. The company noted that the alleged conduct and product sales occurred prior to Boston Scientific's 2006 acquisition of Guidant.
Boston Scientific has received CE Mark for the Promus Element everolimus-eluting coronary stent system, its third-generation drug-eluting stent (DES) technology.
Since the FDA approved the Taxus Liberte Atom 2.25 mm paclitaxel-eluting stent in May, Boston Scientific has gained about 8 percent of the market, according to Jeff Mirvis, vice president of marketing. The company highlighted the Taxus Liberte family of stents, as well as next-generation stents, at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
HORIZONS AMI, which studied 3,602 STEMI patients who underwent primary PCI after two years, continued to find a statistically significant superiority for initial treatment with bivalirudin alone compared with heparin plus GPIIb/IIIa inhibitors, and for drug-eluting stents over bare-metal stents. The study was presented during the late-breaking clinical trials at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on Sept. 25.
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