Wall Street analysts are predicting that Boston Scientific will lay off 7-12% of its worldwide workforce, which would come to between 2000 and 3400 people, the Boston Globe reports. This would occur because of slumping sales in its biggest markets, stents and implantable cardioverter-defibrillators. Other factors: the debt from its $27 billion acquisition of Guidant, and a "corporate warning letter" from FDA that prevented the firm from introducing certain new products. One analyst expects the cuts to disproportionately affect the stent business. Boston Scientific eliminated about 500 jobs earlier this year and said more cuts were forthcoming. The firm has not confirmed when the cuts will be announced, but some analysts think it could come as early as this week. Third-quarter financial results will be announced Friday. It's always tough to hear about the...
October 16th, 2007
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The Securities and Exchange Commission is investigating five orthopedics companies for possible violations of the Foreign Corrupt Practices Act, reports the Associated Press. Four of the five -- Biomet, Smith & Nephew, Stryker, and Zimmer -- recently agreed to sanctions from the Department of Justice over questionable arrangements with doctors. The fifth is Medtronic. The Foreign Corrupt Practices Act prohibits U.S. companies from bribing foreign officials to get or keep business. A Zimmer spokesman does not believe the SEC and DOJ cases are related. All five firms agreed to cooperate with the investigation.
October 15th, 2007
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Medtronic has read more >>
October 15th, 2007
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You know how annoying it is when you have gum stuck to your shoe? How it stretches and can be quite cumbersome to remove? Well, surgeons experience a similar problem when performing secondary heart procedures on patients. Adhesions (fibrous bands of scar tissue) that form in the chest cavity after an initial heart surgery make it difficult and dangerous, due to the formation of new blood vessels interwoven into the tissue, to reach the heart. A bioresorbable polymer antiadhesion barrier, developed by SyntheMed Inc. (Iselin, NJ) is designed to help prevent the formation of the scar tissue. Surgeons can apply the clear film, called Repel CV, over the heart after surgery, and the material is absorbed by the body within 28 days. Data from FDA-regulated trials using the product revealed that a high percentage of patients were free of "clinically-significant adhesions." FDA's Circulatory System Devices Advisory Panel recently recommended the...
October 12th, 2007
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An FDA advisory panel yesterday recommended that the agency approve Endeavor, Medtronic's entry into the drug-eluting stent sweepstakes, the Star-Ledger of Newark, NJ reports. Despite some data showing it is more associated with blood clots than Boston Scientific's Taxus, it has a better overall safety profile than Taxus or Johnson & Johnson's Cypher, the panel found. But how much reward will Medtronic reap? When drug-eluting stents were being developed and when they were first introduced, it was believed the market for them would be huge. But then studies questioning their safety started popping up, and the market shrunk. Even if Medtronic's stent is approved and adopted by some doctors, will it be enough to justify the effort and expense? Especially when Abbott's Xience joins the field?
October 11th, 2007
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Vancouver-based Angiotech Pharmaceuticals (don't be fooled by the name; it's a device company) said that preliminary clinical data for an anti-infective catheter are positive, reports the Associated Press. That means the firm will proceed with a 510(k) submission. The company is evaluating 5-Fluorouracil, an already approved drug, to prevent catheter-related infections, usually caused by bacteria growth. When coated on a catheter, the drug appears to stop bacteria from entering the bloodstream.
October 10th, 2007
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FDA said it will alert doctors to problems associated with two imaging agents that are injected into patients' veins before their hearts are viewed via echocardiography, an ultrasound procedure, Reuters reports. The agency is investigating reports that GE's Optison and Bristol-Myers Squibb's Definity are associated with deaths and severe cardiopulmonary reactions. It is possible the products will be required to carry a "black box" warning, the strongest kind. Definity is currently on the market; Optison was recalled in 2005 because of manufacturing issues and is scheduled for relaunch soon. Only a small percentage of patients who receive echocardiograms are injected with either product.
October 9th, 2007
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Medtronic has been trying to get regulators and clinicians to believe that its drug-eluting stent, Endeavor, should be approved and used over existing products because it is safer. However, clinical data revealed Friday throw a wrench into the claim, Bloomberg News reports. Those data show Endeavor to be more associated with blood clots than Boston Scientific's Taxus. (However, this did not translate into deaths and heart attacks, which were lower for Endeavor patients than Taxus ones.) This is not the best time for such news. Endeavor will be discussed by an FDA advisory panel on Wednesday, after which the panel will decide whether to recommend it for approval. Even if Endeavor does get through FDA, the new data gives Boston Scientific marketing ammunition.
October 8th, 2007
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Siemens, the German conglomerate that makes medical imaging systems, among other things, was fined about $284 million by a German court over accusations of some employees making bribes to secure contracts, reports the Associated Press. That brings to an end one of several investigations. This one focused on the company's failing to report the proceeds to German authorities for tax purposes. Several of the firm's top officials resigned over the scandal.
October 5th, 2007
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A study published in the New England Journal of Medicine suggests that drug-eluting stents might be more effective than their bare-metal counterparts. As part of the study, 7.4% of patients that had the DES needed another procedure within two years to restore blood flow versus the 10.7% rate for those who had a bare-metal stent implanted. And after three years, 5.5% of the patients with the DES had died compared to 7.8% of patients with the bare-metal stents. In other stent news, Medtronic is expecting FDA to approve its Endeavor stent by the end of this year. According to analysts, the device has a safety profile that puts it above J&J and Boston Scientific.
October 4th, 2007
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