St. Jude Medical (NYSE:STJ) advised doctors and patients last week that it’s recalling some of its Eon and Eon Mini pain management implants after hundreds of the neurostimulation devices had to be taken out when their batteries failed too soon or because they overheated while recharging.
Neuros recently received an investigational device exemption from the FDA to evaluate its chronic pain management system, the electrical nerve block, for use in amputee patients to manage pain in the residual limb.
The memo detailed adverse events possibly associated with improper use of its Granuflo dialysis concentrate, including a possible 5-fold increase in heart-attack risk associated with the compound.
MASSDEVICE ON CALL — Health care spending grew only 3.8% in 2009 and 3.9% in 2010, the smallest spending increase in 50 years.
The rate of growth in the health care sector has slowed every year since 2002, but the rates in 2009 and 2010 were especially pronounced, according to the Centers for Medicare & Medicaid Services national health expenditure report.
Update: Saturday, Dec. 10, 2011 – The headline for this story mistakenly reported that the AdaptiveStim system treats DBS pain. It is for treatment of chronic pain.
Medtronic (NYSE:MDT) unveiled clinical data in support of its recently cleared AdaptiveStim pain management implant with RestoreSensor at the North American Neuromodulation Society meeting this week.
MASSDEVICE ON CALL — House Republicans began circulating a proposal to come up with the $38 billion needed to pay for an impending cut in Medicare payments to doctors, Healthwatch reported.
The proposal aims to pay for the payments for two years by increasing rates for high-income seniors on Medicare, repealing unspecified parts of health care reform laws and means-testing.
Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Infinion 16 percutaneous lead, designed for use with the company’s Precision Plus spinal cord stimulator system to control chronic pain.
The Infinion 16 lead is the first 16-contact percutaneous lead on the global market, doubling the previous max of eight stimulating contacts, according to the Natick, Mass.-based med-tech titan.
St. Jude Medical Inc. (NYSE:STJ) won Japanese regulatory approval to market its Penta surgical lead for neurostimulation therapy to treat chronic pain.
The leads are used to provide electrical impulses near the spine to mask or interrupt pain signals. The lead is arranged in five columns to selectively stimulate certain nerves associated with the patient’s area of pain without affecting other nerves, according to a press release.