Only 16 implantable cardioverter defibrillators (ICDs) per million inhabitants were implanted in France last year, compared to 70 in Germany, 55 in Belgium, 40 in Italy, 22 in Great Britain and 20 in Portugal, according to reports in the Quotidien du Medecin. Professor Jean-Paul Fauchier, president of the French cardiology society, estimates that about 10,000 of the sudden cardiac deaths in France each year result from tachycardia – or fibrillation – and could be avoided by implantation of defibrillators.
This situation has arisen because at present, implantable defibrillators are not reimbursed by the national health insurance system. In addition, implantation is permitted only in public hospitals, which must finance the cost of around $14,000 each from their own budgets. Historically, the French government has refused reimbursement of implantable defibrillators because of worries that expenditure in this area could spiral out of control.
Reimbursement for defibrillators in Europe is still not widespread, and growth in sales of 10% to 15% this year over last year's $290 million is the best that can be expected.
Spanish regions install AEDs
The Spanish regions of Catalonia and Galicia are planning the installation of automatic external defibrillators, starting with equipping their ambulances.In Galicia, 100 ambulances will be equipped with AEDs, with more than 250 ambulance crew members trained in their use. A similar project in Catalonia involving more than 200 ambulances has been delayed for legislative reasons.In both regions, the next stage will be the installation of AEDs in public places such as railroad stations and soccer stadiums for so-called "passerby" use by untrained members of the public.
ECG by phone
IMA Service (Berlin, Germany) has started a trial service for heart patients in Dresden in eastern Germany. For a charge of about $113 a month, IMA Service provides a "cardiophone" that transmits electrocardiogram results by phone to the city's ambulatory heart center. The information can then be used to determine the likelihood of a heart attack and to decide if early remedial action is necessary. A majority of German statutory health insurers have already agreed to reimburse the device as a medical aid.
Relief of MI-associated pain
Advanced Pain Management (APM; Blackburn, England) has developed a noninvasive spinal column stimulation device for relieving acute pain. The company says the device is the first of its kind that can be used to relieve pain associated with suspected myocardial infarction.
The high-frequency transuctaneous spinal electoanalgesia (TSE) device operates at between 20,000 and 50,000 Hz frequencies. Energy is delivered through two surface electrodes placed at the upper and lower ends of the spinal column. This stimulates the central nervous system to block pain signals traveling to the brain. APM has received CE marking for European sale based on a 206-patient trial that achieved 50% to 100% pain relief in about 10 minutes. The company anticipates a price to users of around $715.
Thermocore's plaque detection catheter
Thermocore Medical Systems (Ghent, Belgium) has developed a catheter-based system for the location and visualization of unstable vulnerable plaque within coronary arteries. The system incorporates an array of sensitive temperature sensors mounted on a catheter to map the interior of coronary arteries, based on temperature variations that point to areas where vulnerable plaques occur.
An earlier prototype version showed greater thermal variations in patients with unstable angina and myocardial infarction than in a control group with normal coronary arteries, according to Thermocore. Cambridge Consultants (Cambridge, England), a subsidiary of Arthur D. Little, is collaborating with Thermocore on the development of software for the final version of the device, which is expected to be ready for clinical trials in six to eight months, with a European product launch in 2002.
Actelion shares down as heart drug fails
Shares in Actelion (Allschwil, Switzerland), one of the leading Swiss biotechnology companies, fell by more than 60% after Valetri, the first in a new class of heart drugs, failed at the final stages of Phase III clinical trials. The news caught the market by surprise after results from a separate trial in March showed that Valetri significantly increased blood flow in patients with acute heart failure. The company said it was too soon to say why the new trials came to different conclusions, but that there was no reason to suppose Valetri would not gain approval. "The most likely scenario is this will delay approval by 12 to 18 months," Actelion said.
Actelion and Genentech (South San Francisco, California) recently signed an agreement for the development and co-promotion of Actelion's endothelin receptor antagonist Tracleer (Bosenstan) in the U.S.