FDA reviewers expressed concern with the increased number of cancer cases seen in degenerative disc disease patients implanted with an investigational Medtronic spine device compared with patients who underwent spinal fusion. The Amplify device stabilizes lower back vertebrae in patients with degenerative disc disease by using a compression resistant matrix and a metallic posterior spinal instrument. Amplify contains rhBMP-2, a morphogenetic protein that is added to the device to spur the formation of new bone.

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The FDA initiated a class I recall its strictest of two infusion pumps released by a single company, due to a device error which may fail to recognize in-line air in infusions. Device manufacturer Hospira warned that failure to make corrective actions before device use may cause air to be delivered to the patient and cause serious injury or death. The company has not received any adverse event reports related to device failure.

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A new study by Aussie scientists has shown that women who go for a hysterectomy or removal of ovaries via keyhole surgery are half as likely to suffer complications than those that opt for open abdominal surgery. The results of the new study hope to provide women with a quicker and less traumatic recovery from uterine cancer treatment. The trial assessed 759 patients who were enrolled through 20 gynecological cancer centres worldwide.

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The researchers at Rush University Medical Center found that 78 percent of athletes suffering from hip labral tear caused by internal ball and socket joint damage to the hip were able to return to their sport within an average of a little more than nine months following the surgery. Hip arthroscopy is a less invasive outpatient procedure compared to traditional open hip surgery.

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The FDA has laid out requirements for the recall of Colleague Volumetric Infusion pumps by Baxter Healthcare Corp., instructing the company on how to refund or provide replacements for about 200,000 potentially dangerous infusion pumps. The FDA announced the infusion pump recall requirements, a little more than two months after it announced that Baxter would be forced to take its Colleague pump off of the market. Problems with Baxter Colleague infusion pumps have been linked to more than 500 deaths and 56,000 reports of adverse events.

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NuOrtho Surgical, a surgical instrument developer based at the Advanced Technology and Manufacturing Center, has received FDA clearance to market its surgical probe. The approved probe, called Ceruleau, is NuOrtho’s first device to hit the market. NuOrtho received FDA clearance sooner than expected, Jeffrey Morrill, NuOrtho’s CEO, said. The company is now working to ramp up manufacturing and line up distributors. Within the next few months, as Ceruleau hits the market, the small company plans to hire about 20 people.
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Given Imaging Ltd announced that the first in-human study analyzing remote magnetic manipulation of a PillCam video capsule was published in the June 2010 edition of Gastrointestinal Endoscopy. Gastrointestinal Endoscopy is the journal of the American Society for Gastrointestinal Endoscopy, which validates the potential of magnetic maneuvering of the PillCam capsule endoscope. “This study demonstrated two things: 1] we can maneuver capsule in humans and 2] that the procedure is painless. We believe that these results underscore the value of conducting additional clinical studies in humans,” said Dr. Paul Swain of the Imperial College, London, United Kingdom. “Remote manipulation may improve diagnostic accuracy and is essential for the future development of remote controlled therapy by video capsules,” GIVN said.

Israel’s PolyTouch Medical has received FDA clearance to market its PatchAssist laparoscopic hernia mesh placement device. The tool was developed to allow surgeons a more predictable and standardized approach to apply hernia patches. PatchAssist easily unfolds the mesh inside the abdominal cavity, accurately places the mesh over the hernia defect and enables surgeon to verify the mesh position before attachment is made. Patch Assist does not change laparoscopic techniques used today by surgeons, rather it eliminates manual, complicated, and time consuming tasks.