Biopure's (Cambridge, Massachusetts) Hemopure oxygen therapeutic has been approved by South Africa's Medicines Control Council for the treatment of acute anemia and in reducing the need for allogenic red blood cells. Results from Biopure's advanced red blood cell controlled trials in cardiac, vascular and general surgery showed a statistically significant percentage of patients who received Hemopure and who, as a result, did not need red blood cell transfusion, according to the company.
Hemopure is licensed in sub-Saharan Africa to Tshepo Pharmaceuticals (Johannesburg, South Africa), a joint subsidiary of Network Healthcare Holdings (Netcare) and Community Healthcare Holdings (both Johannesburg). Tshepo plans to launch Hemopure nationally in the first half of next year after Biopure completes expansion of its Cambridge facility to handle an annual production capacity of 100,000 Hemopure units. In the interim, Biopure will supply the product at no cost for use at a small number of Netcare hospitals where patient outcome data will be collected to demonstrate the pharmacoeconomic implications and cost-effectiveness of the new treatment.
"This unique oxygen carrier could profoundly impact public health issues in Africa as the product's purity, compatibility with all blood types, and two-year room-temperature stability address many of the medical and logistical problems surrounding the treatment of anemia with red blood cells," said Richard Friedland, Netcare COO. Hemopure is the first product to be approved for human use to deliver oxygen to the body's tissues as a sterile alternative to red blood cell transfusion.
"This approval culminates almost two decades of technological innovation and product development," said Carl Rausch, Biopure chairman and CEO, who co-founded the company with David Judelson, vice chairman, in 1984. "Hemopure's introduction in South Africa is the first step in our worldwide commercialization strategy, and we are preparing to file a U.S. marketing application later this year, followed by filings in Europe and other countries."
Other hemoglobin-based oxygen carriers (HBOCs) are under development by Baxter Healthcare (Deerfield, Illinois) and Northfield Laboratories (Evanston, Illinois), both of whose products are based on human hemoglobin, whereas the Biopure product is produced from bovine red blood cells. Baxter's second-generation recombinant human hemoglobin is in development to replace HemAssist, a modified human hemoglobin that was withdrawn after clinical trials were halted in 1998. Northfield Laboratories' PolyHeme is in Phase III trials. Both HemAssist and PolyHeme are produced from blood cells discarded from blood banks, a supply source that is projected to disappear as tougher blood collection screening reduces numbers of donors. In contrast, the problem with Baxter's recombinant approach may be one of cost, particularly since a major market area for HBOCs is likely to be in developing countries where blood banks are non-existent or where there is real concern regarding sourcing blood from donors more likely to be infected with viruses, bacteria or parasitic agents.
Central venous catheterization risks
Britain's Medical Devices Agency (MDA) has completed an investigation into risks associated with central intravenous catheterization, particularly in neonatal parenteral feeding, and plans to issue a full report shortly. The investigation was ordered following four neonatal deaths resulting from cardiac tamponade during central venous catherization procedures.
The MDA in its report emphasizes that "catheter tips should no longer be placed within the heart." The agency says that the presence of a catheter tip inside the atrial cavity can result in myocardial erosion, pericardial diffusion or cardiac tamponade. The agency also recommends that catheters should be positioned with the tip at the junction of the inferior or superior vena cava and right atrium, but outside the heart. Correct positioning should be verified by X-ray during insertion, and the MDA plans discussions with catheter suppliers to discuss ways to augment the radio-opacity of the catheter tips for better imaging. The agency also recommends the use of fully sterile insertion techniques and external fixation to lessen the risk of migration of the catheter into the heart cavity.
Ambulatory and portable BP monitoring
Progetti (Turin, Italy) has launched its PG Map compact ambulatory blood pressure monitor (ABPM), which weighs less than 300 grams, including batteries. The company says that this new, low-cost monitor, which uses the straightforward oscillometric technique, interfaces with PG Win Pro software to make possible pre-set patient specific monitoring programs.
Amluck (Taipei, Taiwan) has launched its AK-3000 automatic digital wrist blood pressure monitor in Europe. The device also measures oscillometrically and uses fuzzy logic software.
Omron (Kyoto, Japan) has on general release in Europe its Omron 907 all-in-one blood pressure monitor for physicians' office and clinic applications. With this desktop device, blood pressure can be measured oscillometrically or by using the auscultatory method, whichever is preferred.
Another noninvasive blood pressure (NIBP) monitor for continuous bedside monitoring in the ICU or recovery room is available from Elmed (Augsburg, Germany) and features alarms for systolic and diastolic pressures as well as pulse rate.
The Elan monitor from Medlab (Karlsruhe, Germany) also incorporates a full alarm system but has measuring capabilities for three-channel ECG, pulse oximetry and respiration as well as NIBP. Since operation of the Elan is completely icon-oriented, it can be used in any country without having to select appropriate language programs.
Clopidogrel effective against heart attacks
The CURE international clinical trial involved more than 12,500 patients with either unstable angina or non-Q-wave myocardial infarction (NQMI) in 482 hospitals in 28 countries. Results showed that clopidogrel in addition to standard therapy, including aspirin, reduced the risk of atherothrombotic events compared to patients receiving standard therapy alone. The study also confirmed a synergistic effect of clopidogrel and aspirin. The benefit surprisingly was in addition to and independent of other therapies, such as anticoagulants, beta-blockers and lipid-lowering agents.
The study, which was coordinated by the Canadian Cardiovascular Collaboration at McMaster University (Hamilton, Ontario), was supported by grants from Sanofi-Synthelabo (Paris), the developers of clopidogrel, and Bristol-Myers Squibb (New York), which with Sanofi-Synthelabo is co-marketing the drug.
"The CURE study provides important new findings that constitute a major step forward and could lead to a very significant improvement in the treatment of patients at risk of heart attack, stroke and cardiovascular death," said Salim Yusuf, professor of medicine at McMaster, principal investigator in the trial.
Image acquisition technique speeds exams
Philips Medical Systems' (Best, the Netherlands) SENSE (Sensitivity Encoding) magnetic resonance image acquisition technique greatly increases frame rates in cine studies and provides cardiologists with access to speedier examinations with fewer and shorter breath holds.
The technique is based on the use of phased-array coils and multiple receivers and makes use of a parallel imaging approach to speed image acquisition. Research groups have obtained imaging speeds of more than 90 frames per second in cardiac applications, according to the company.