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News: Setember 11, 2007

Pressure Sensors for the Eye Undergoing Clinical Testing.  A sensor developed by researchers at the Fraunhofer Institute for Microelectric Circuits and Systems IMS in Duisburg may prevent patients with glaucoma from requiring repeated trips to the doctor to monitor the pressure in their eyes.  The electrode sensor, which does not impair the patient’s vision, is implanted into the patient’s artificial lens.  Using a tiny antenna, the implant sends pressure data to a reader that is fitted into the frame of a pair of glasses. The patient can then view the results and determine whether the pressure has reached a critical level.  The sensor is currently undergoing clinical testing.  Additional information is available at http://www.medicalnewstoday.com/articles/81940.php.

Diagnostic HYBRIDS Announces Release of D3(R) DFA Varicella-zoster Virus Identification Kit.  Diagnostic HYBRIDS announced the release of its D3(R) DFA Varicella-zoster Virus Identification Kit, which use and utilizes a blend of proprietary monoclonal antibodies directed against two specific VZV proteins.  When used in combination with the H&V Mixed Cell culture system, results can be obtained in as little as 20 hours, allowing clinicians to identify these infections while VZV antiviral treatment is still possible.  Additional information is available at http://www.devicelink.com/newsedge/.

Preliminary Recommendations Would Stop Payments for Drug-Eluting Stents In Britain.  A committee recently met to discuss whether to move forward with preliminary recommendations for the National Health Service of England and Whales to stop paying for drug-eluting stents.  Although the UK market is only a fraction of the worldwide market, it may create a precedent for other European countries, generating a much larger impact on this sector of the medical device market.  The meeting was sparked by dramatic new data about the risks of late stent thrombosis and clinical results questioning the value of intervention versus medical therapy in certain cardiac patients.  Despite these data, the medical community of Britain remains strongly opposed to the NICE’s preliminary appraisal.  Additional information is available at www.thegraysheet.com (paid subscription service).

CMS Panel to Consider Home Testing for Sleep Apnea.  A Medicare advisory panel will meet on September 12, 2007, to consider the effectiveness of portable home monitors in diagnosing obstructive sleep apnea.  The outcome of the meeting will inform CMS deliberations on whether to extend coverage for continuous positive airway pressure (CPAP) to patients diagnosed with the condition using a portable monitor.  Currently, patients must be diagnosed following polysomnography measurement performed at a sleep study laboratory for Medicare to cover CPAP.  Additional information is available at www.thegraysheet.com (paid subscription service).

AdvaMed Seeks Changes in CMS Payment Process for New Diagnostic Tests.  Diagnostic manufactures are urging CMS to use a more transparent and informed process to determine payment rates for new diagnostic tests.  Specifically, AdvaMed is pushing CMS and Congress to make changes to the “gap-fill” process for determining payment levels for new tests.  In all cases, AdvaMed wants to be able to see the data and methodology on which the gap-fill amount is based.  The group also wants CMS to articulate the principles that should be followed to ensure that the data used is statistically significant and the rationale for other factors use to make the decision.  More information is available at www.thegraysheet.com (paid subscription service).

Human Thrombin Approved by FDA for Topical Use in Surgery.  Evithrom, a protein that helps control bleeding during surgery, is the first human thrombin approved since 1954.  According to FDA, it will be the only such product on the market.  It is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical.  Evithrom is derived from human plasma from U.S. donors, and may prevent the immunogenic response some patients have to bovine-derived thrombin.  It will be marketed as a standalone thrombin as well as in conjunction with the absorbable gel sponge Surgiflo hemostatic matrix with FlexTip.  Additional information is available at  http://www.thegraysheet.com (paid subscription service) and  http://www.fda.gov/bbs/topics/NEWS/2007/NEW01690.html

Edwards Lifesciences PediaSat Oximetry Catheter Introduced.  Clinicians formerly had to rely on manual, intermittent blood sampling to monitor a child’s oxygenation status in a critical care setting, incurring risks of multiple blood draws, infection, and increased potential for transfusions.  The PediaSAT is a real-time, continuous monitoring device designed specifically for children.  The central venous catheter uses fiber optic technology to monitor and identify changes in oxygen-saturation of venous blood.  Additional information is available at:   http://dialog.newsedge.com.      

Biodegradable Screw Cleared.  FDA granted clearance to market the Inion Hexalon screw in the U.S. for use in surgery on several parts of the body - shoulder, elbow, ankle, foot, hand and wrist.  It was originally designed for use in the knee for repair of the cruciate ligament.  The screw fixes soft tissue to bone, is colored to make surgery easier and completely degrades within two years.  Additional information is available at:   http://dialog.newsedge.com and  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=24495

Results of I-Flow ON-Q Prospective Human Study in Colorectal Surgery to be Presented.  ON-Q is a small balloon pump that holds and automatically delivers a local anesthetic through a catheter specially designed to provide even distribution of local anesthetic over a wider area than other catheters.  The device is currently labeled to reduce pain better than narcotics and to significantly reduce narcotics intake after surgery.  The results of a study designed to test ON-Q for reduction of surgical site infections, thus expanding its clinical benefits beyond pain relief, will be presented on September 18th at the Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) in Chicago.  Additional information is available at: http://dialog.newsedge.com.