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New Jersey-based Derma Sciences Inc. began marketing a wound dressing that uses honey to kill germs and accelerate healing. Medihoney is made from an absorbent seaweed-based material that is saturated with manuka honey. The potent kind of honey originates from the hives of bees in Australia and New Zealand. Two types of the dressings are available in North and South America through a deal with Comvita, a supplier in New Zealand that controls about 75% of the world’s manuka honey supply, according to the Associated Press. 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 Diabetes Care has recalled test strips for its Contour TS Blood Glucose Meter, reports Reuters. The strips might show readings that are 5-17% too high, FDA said. The firm blamed the problem on new manufacturing equipment and said it has fixed the problem. About 53 production lots, totalling about 230,000 bottles of strips, were affected. The lot numbers are posted on an FDA Web site. Strips for other meters are not affected, nor are the meters themselves.

Philips announced that it will pay $66 per share, or about $5.1 billion, to acquire Respironics, the global leader in the treatment of obstructive sleep apnea, a condition in which patients repeatedly stop breathing during sleep. 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.

The U.S. District Court in Boston has issued a permanent injunction against Medtronic, banning the company from making, using, or selling its Vertex and Vertex Max polyaxial screws. All subsidiaries, affiliates, and distributors of the screws must return the products to Medtronic. The ruling followed a federal jury’s finding that Medtronic infringed on a polyaxial screw technology patent that is owned by Biedermann Motech GmbH and exclusively licensed to DePuy Spine Inc. According to a DePuy news release, the jury awarded Biedermann Motech and DePuy Spine $226.1 million in damages after a trial in September.

Looking to rebound after a year of financial scandals, neurostimulation firm Cyberonics has been active with patents lately. On Tuesday, it signed an agreement with Johnson & Johnson’s Ethicon Endo-Surgery granting EES the rights to Cyberonics’ patents pertaining to Vagus Nerve Stimulation related to treating obesity, as well as treating diabetes and hypertension in overweight people. 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 is making a play for the Asian spinal market. It has agreed to buy a 15% stake in Shandong Weigao Group Medical Polymer Co. for $221 million, reports Bloomberg News. The firms have formed a joint venture to market spinal products and orthopedics in China. 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.

 

In efforts to focus on their core competencies, one device giant has sold of its retail business, and one pharmaceutical giant has sold off a device business. Covidien announced that it will sell its retail business to First Quality Enterprises, Inc. for about $335 million. The unit includes infant care, feminine hygiene, and adult incontinence products. 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 will issue new, more stringent testing guidelines for drug-eluting stents, CDRH Director Daniel Schultz told the Wall Street Journal. The guidelines are expected to cover things like how many patients should be involved in premarket and postmarket studies, and how long the studies should go. They could also recommend how long patients should stay on anti-clotting drugs after implantation. Expect DES studies to get even more costly than they already are.

An FDA advisory panel has recommended the approval of Hologic Inc.’s Adiana female contraception device for permanent sterilization. The device is used as an alternative, minimally invasive method to tubal ligation and can be performed in a doctor’s office using local anesthesia. 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.

If you’re a patient with a recalled device implanted in your body, do you expose yourself to risky surgery to remove it, or do you leave it in and hope for the best? A story in today’s New York Times follows one patient as he goes through this decision-making process and ultimately has surgery to have his implantable cardioverter-defibrillator replaced. He is one of many patients affected by Medtronic’s recall of faulty leads for its ICDs. 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.