CryoCor Ablation For Atrial Flutter Is Approvable With Conditions - Panel.  CryoCor’s cryoablation system is approvable for treatment of isthmus-dependent atrial flutter, FDA’s Circulatory System Devices Panel concluded in an 8-2 vote June 27.  Six month freedom from recurrence of atrial flutter did not meet the trial endpoint of 90% effectiveness with a lower 95% confidence bound of 80%.  However, a third party readjudicated the event monitor recordings, netting 10 more treatment successes for a success rate of 81.6% with a lower confidence bound of 74.7%.  A subsequent company reanalysis that did meet the endpoint was disregarded by the panel because it was not blinded and because it did not address successes that might be deemed failures by clinicians.  Despite difficulty with the chronic effectiveness endpoint, CryoCor met the acute effectiveness endpoint, with 87.5% of patients achieving successful block of electrical signals immediately after treatment.  Additional information is available at www.thegraysheet.com  (paid subscription service).

FDA Clears for Marketing First Quick Test for Malaria.  The U.S. Food and Drug Administration has cleared for marketing the Binax NOW Malaria Test, the first authorized U.S. rapid test for malaria, a mosquito-borne disease caused by a parasite. The test is intended for laboratory use.  Standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope, a difficult task that requires training and experience. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can also differentiate the most dangerous malaria parasite, Plasmodium falciparum, from less virulent malaria parasites. Results still need to be confirmed using standard microscopic evaluation.  Additional information is available at www.fda.gov/bbs/topics/NEWS/2007/NEW01659.html.

Medtronic Launches Remote Monitoring System For Diabetes.  Medtronic is applying the remote monitoring concept of its CareLink cardiac network to diabetes management.  It will allow health care providers to access and analyze data from their patients’ insulin pumps or glucose monitors.  Medicare currently has no specific reimbursement codes for either cardiac or diabetes remote monitoring. Additional information is available at www.thegraysheet.com  (paid subscription service). 

CMS To Reconsider Coverage For Chronic-Wound Treatment Technology.  CMS has agreed to reconsider its reimbursement policy for the use of autologous blood products in treating chronic, non-healing wounds.  CMS, at the request of Cytomedix, is revisiting a prior non-coverage decision of 1992, reaffirmed in 2003.  Cytomedix is currently seeking FDA clearance for its AutoloGel autologous PRP gel for the treatment of chronic wounds.  Additional information is available at www.thegraysheet.com  (paid subscription service).

White Paper – “Combination Products: Pathways to Approval.”  A new white paper from FDC Reports provides an extensively researched listing of approved combination products, and information about how these products gained approval.  Additional information is available at www.thegraysheet.com  (paid subscription service).