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Articles from 2007 In December

Honey Fights Superbugs

Derma Sciences hopes to have the dressing in U.S. drug stores within the next six months, and adhesive strips should be available soon after that. Advocates of the product state that it reduces inflammation, odors associated with infections, and prevents the MRSA staph infection from infecting open wounds. Following FDA approval, Medihoney generated $150,000 in sales in just 10 weeks. Derma Sciences' CEO Ed Quilty said he plans on doubling the company's sales force next year.

Bayer Recalls Diabetes Test Strips

The lot numbers are posted on an FDA Web site. Strips for other meters are not affected, nor are the meters themselves.

Sleep Apnea Therapy Hits the Big Time

Between 15 million and 20 million people in the United States suffer from it, and it has been linked to heart disease, stroke, and diabetes. Respironics is best known for its continuous positive airway pressure (CPAP) devices, but it offers a number of products for respiratory-impaired patients. The Respironics board of directors has approved the offer and is encouraging shareholders to sign off on it as well.

Federal Court Orders Permanent Injunction against Medtronic

According to a DePuy news release, the jury awarded Biedermann Motech and DePuy Spine $226.1 million in damages after a trial in September.

Cyberonics Makes Patent-Related Moves

Cyberonics will receive $9.5 million up front and royalties on the sales of the products. Today, Cyberonics announced that it has acquired patents giving it the rights to Vagus Nerve Stimulation for treatment of stroke and traumatic brain injury. The patents were licensed from Southern Illinois University.

Medtronic, Philips Make Deals

Right now only 7% of China's population is over 65, but that number is expected to increase to 20% by 2040, making the orthopedics market there potentially very lucrative. Meanwhile, Philips Medical Systems said it would buy Visicu (Baltimore), a clinical IT company, for about $430 million. Visicu has remote patient monitoring and clinical decision support technology that can be integrated with Philips' patient monitors. This could allow hospitals to monitor greater numbers of clinically ill patients while receiveing better clinical decision support.  

Covidien, BMS Sell Off Units

Likewise, drugmaker Bristol-Myers Squibb will sell its medical imaging unit to private equity firm Avista Capital Partners for about $525 million. Avista is the same firm that bought Boston Scientific's fluid management and venous access businesses last week for $425 million.

FDA To Beef Up DES Testing Requirements

FDA Recommends Contraception Device for Sterilization

In a 10-3 vote, FDA recommended the approval under certain conditions, including long-term follow up of current pivotal trial patients, more specific labeling, and a new postapproval study of new patients and doctors. The procedure, which takes about 15 minutes, uses radio signals to make a lesion inside the fallopian tube. Once a catheter introduces a soft material (smaller than a grain of rice) into the tube, tissue grows on and around the material to create a permanent blockage. Women can resume their normal activities in one day, versus conventional bilateral tubal ligation, which is performed under general anesthesia and requires a four- to five-day recovery period. The device's pregnancy prevention efficacy rate is 98.9% after one year.

In Advance of Safety Meeting, Patients Face Tough Choice

In fact, the issue with the Fidelis leads is the "most widespread problem yet involving a heart device," says the Times. Yet, the financial impact on Medtronic has been less than expected, because it moved so quickly to correct the problem, and because most doctors are recommending that the leads be left in place, with monitoring stepped up. This is why there's a very significant meeting going on today. CDRH officials, doctors, and representatives from device companies are meeting in Boston to discuss how components of heart devices are regulated and consider proposals about how heart devices should be approved and monitored. Expect some important recommendations to eventually emerge. UPDATE: According to a Wall Street Journal blog entry, the session focused on the inadequacy of lab tests to detect lead breakage and the infrequency of doctor reports about it. But there doesn't yet appear to be a consensus about what to do about these things.