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Less than two weeks after a Delaware jury said a Boston Scientific stent design infringed a patent held by Johnson & Johnson (J&J), a different federal jury ruled that J&J's Cypher drug-eluting stent infringed a patent held by Boston Scientific.
The recent rash of highly publicized malfunctions and recalls regarding implantable cardioverter-defibrillators (ICDs) manufactured by companies including Guidant, Medtronic and St. Jude has led some industry analysts and patients to question whether implantable devices are lifesavers or the source of additional patient risk.
The FDA’s Circulatory System Device panel last week recommended against the agency approving a device designed for patients with progressive heart failure characterized by an enlarged heart and decreased pumping function.
St. Jude Medical has voluntarily notified physicians serving patients who have received certain models of the company’s implantable cardioverter-defibrillators (ICDs) that such patients are in need of noninvasive software upgrades to their devices to correct two product anomalies.
Stent maker Boston Scientific was found guilty by a U.S. District Court jury last week of infringing patents held by rival New Brunswick, N.J.-based Johnson & Johnson (J&J) and its Cordis subsidiary.
Guidant told doctors June 24 to stop implanting certain defibrillator models in patients, citing a problem with a magnetic switch in the devices that may become stuck in the “closed” position.
The Maharashtra FDA — a Food and Drug Administration in India— has asked drug-eluting stent manufacturers and importers to obtain drug licenses from the Drug Controller General of India within the next two months.
The FDA has cleared Medtronic’s “pain pacemaker,” SynergyPlus+, a device designed to give patients more control over the delivery of electrical stimulation to block pain signals from reaching the brain.
Edwards Lifesciences has voluntarily delayed patient enrollment in its U.S. percutaneous aortic heart valve feasibility trial after serious complications with participants leading to the death of at least one patient.
MIV Therapeutics (MIVT) will license two technologies from the University of British Columbia (UBC) for advanced biocompatible and drug-eluting coatings for stents and other medical devices, the company announced last week.