INSIDE: - Medical Device Daily

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 10 OF 10P RODUCTB RIEFSBiopure reports initial sale ofHemopure in South Africa• Abbott Point of Care (East Windsor, New Jersey)reported that it has received FDA 510(k) clearance to marketits i-Stat Chem 8+ cartridge, a new point-of-care diagnostictest used to quickly assess basic metabolic status ofpatients in emergency rooms and other critical care settings.The Chem 8+ cartridge is designed for use with the i-Stat, an automated hand-held blood analyzer that performsa comprehensive panel of critical tests at the patient’s bedsidein only a few minutes, producing lab-quality resultsthat allow healthcare professionals to make on-the-spotdiagnosis and treatment decisions for their patients. TheChem 8+ cartridge is a single-use, in vitro diagnostic testthat combines a battery of basic metabolic tests withmeasurements for hematocrit and hemoglobin into a singletest. The i-Stat Chem 8+ cartridge provides a rapid snapshotof the most critical homeostatic processes: glycemiccontrol, electrolyte balance and renal function, right at thepatient’s side and using just a few drops of blood.• Advanced Medical Optics (Santa Ana, California)said that its Tecnis foldable intraocular lens (IOL) has beendesignated as a New Technology Intraocular Lens (NTIOL)by the Centers for Medicare & Medicaid Services (Baltimore).The designation follows labeling claims approvedby FDA in April 2004 that the Tecnis foldable IOL reducedpostoperative spherical aberrations compared to lenseswith spherical optics and improved night driving simulatorperformance. The NTIOL designation goes into effect Feb.27 and includes both the acrylic and silicone platformTecnis lenses. The company said the Tecnis IOL is the onlylens approved for NTIOL reimbursement status, which providesfor additional Medicare reimbursement of $50 perlens for ambulatory surgical centers, which perform morethan half of all cataract surgeries in the U.S.• BrainStorm Cell Therapeutics (Tel Aviv, Israel),developer of NurOwn bone marrow-derived stem cell therapeuticproducts for the treatment of neurodegenerativediseases, said a patent application has been filed with theU.S. Patent and Trademark Office for a new procedure toderive oligodendrocyte-like cells. The invention involvesinducing oligodendrocyte-like cells using the company’sbone marrow-derived human mesenchymal stem cell technology.The patent application was filed by Ramot, the technologytransfer company of Tel Aviv University, on thebasis of research funded by Brainstorm . Worldwide rightsto the development and commercialization of the newtechnology are exclusively licensed to BrainStorm.• CardiArc (Lubbock, Texas) said it has received 510(k)clearance from the FDA to market its new cardiac singlephoton emission computed tomography (SPECT) imagingdevice, which the company said could lead to better cardiacdiagnosis and fewer hospitalizations to rule out heartA Medical Device Daily Staff ReportBiopure (Cambridge, Massachusetts) yesterdayreported that it has made the first commercial sale of itsoxygen therapeutic Hemopure (hemoglobin glutamer —250 (bovine)), with that sale coming in South Africa.The product is approved in South Africa for the treatmentof adult surgical patients who are acutely anemicand for the purpose of eliminating, delaying or reducingthe need for allogenic red blood cell transfusions in thesepatients.“This first-ever commercial sale of a hemoglobinbasedoxygen therapeutic for human use is a milestonein the field of oxygen therapeutics and representsdecades of research and development by the company,”said Zafiris Zafirelis, Biopure CEO and chairman. “It is alsoan important step in understanding how doctors perceiveand use the product outside of clinical trials.”Biopure said its initial sales targets are providers thathave used or been trained to use Hemopure as part of apost-approval medical education program. In April 2001,South Africa’s Medicines Control Council granted marketingclearance for the product (Medical Device Daily,April 2001). However, it said that issues between Biopureand the original product registration holder and distributordelayed marketing and sales.In 2005, Biopure acquired control of the product registration,selected a warehousing and shipping agent andappointed a sales agent. And in early January, the companyreported that it had complied with new import regulationsand shipped product to South Africa to supportthe initiation of sales and marketing activities.The company said it plans to apply in Europe, in mid-2006, for approval of an acute anemia indication inorthopedic surgery patients.Hemopure has not been approved for sale in otherjurisdictions, including the U.S. or the European Union.attacks. It said physicians soon would have sharper imagesof blood flow and function of their patients’ hearts, in halfthe time previously required. CardiArc has developed andpatented a new, smaller and faster technology for SPECTwith twice the resolution of existing devices. The CardiArcsystem is the size of an executive chair, runs on 110 volts ACcurrent and fits easily in a 6-foot by 7-foot exam room withoutremodeling. The device has no visible moving parts anduses solid-state cadmium zinc telluride (CZT) technology.Patients sit upright, without rotating or holding their armsover their heads. Scan times range from 2 minutes to 6 minutesat physician discretion. The company said theCardiArc SPECT device has been designed for use in outpatientsettings and emergency rooms.To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.