Cardiac rhythm management company ELA Medical (Monrouge, France) last month reported the European release of Symphony AAIsafeR 2, its second-generation pacemaker that minimizes ventricular pacing. The company said the AAIsafeR 2 pacing mode is intended to promote the patient's intrinsic electrical conduction by "drastically limiting" the amo- unt of "unnecessary, often deleterious pacing delivered to the right ventricle."
It said that permanent checks of the patient's natural conduction allows the Symphony AAIsafeR 2 pacing system to deliver right ventricular pacing when normal conduction of the cardiac impulse to the ventricle does not occur. When intrinsic conduction resumes, ELA's new device automatically switches back to physiological AAI pacing. The company said the AAIsafeR 2 builds on its clinically proven Symphony pacing systems with AAIsafeR mode that was launched in Europe in September 2003, according to ELA Medical.
The launch was effective immediately, ELA said, and will be accompanied by a special Privilege Program running until the end of this month, aimed at medical institutions that implanted the first generation of Symphony systems, during which those facilities will have the opportunity to upgrade all Symphony to Symphony AAIsafeR 2 pacing systems.
The company said that several clinical studies have shown that over-pacing the right ventricle may increase the risk of developing heart failure and atrial fibrillation, conditions known to be major cost-drivers for healthcare systems worldwide. ELA Medical said AAIsafeR 2 manages to reduce ventricular stimulation to 0.1% in patients with intermittent atrio-ventricular conduction. That represents as little as 1 minute, 30 seconds of ventricular pacing per day, or nine hours per year, the company said.
With the new device, unnecessary ventricular pacing is 40 times less than with other systems available on the market, said ELA, a Sorin Group (Milan, Italy) company. It said that, unlike other devices that attempt to minimize ventricular pacing, Symphony AAIsafeR 2 "not only addresses patients with bradycardia caused by sinus node dysfunction, or brady-tachy syndrome ... [but] also is indicated for patients with any type of transient atrio-ventricular blocks, permanent first-degree blocks and paroxysmal atrial fibrillation."
In addition, it said that Symphony AAIsafeR 2 is "the only pacing system capable of managing atrio-ventricular conduction disorders that may occur at exercise or at night." Altogether, ELA said the new product "efficiently withholds deleterious ventricular pacing in 60% of dual-chamber paced patients." Minimized ventricular pacing not only offers enhanced patient comfort, it also extends the device longevity by two years, the company said.
Symphony AAIsafeR 2 is the first product in ELA's new generation of CRM products to include the AAIsafeR 2 mode. The company said its next implantable cardioverter defibrillator, which will be launched late this year, also will feature the advanced pacing mode.
CE mark sought for HeartMate II
Thoratec (Pleasanton, California) said last month that it had filed for CE mark approval of its HeartMate II LVAS (left ventricular assist system). Approval would allow the commercial launch of the device in Europe. The HeartMate II is a next-generation heart-assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. Thoratec received approval in February to begin a Phase II pivotal trial for the device in the U.S., and last month reported that the first patients have been enrolled in both the destination therapy (DT) and bridge-to-transplantation (BTT) arms of that trial.
The regulatory application for European approval is based on data from the first 20 patients that were implanted in Thoratec's Phase I U.S. trial and in a European study. These patients accounted for nearly 5,200 days of cumulative support and were each supported from three to 490 days. The company said it hopes to receive the CE mark for the device this year.
"Our application seeks approval to use the HeartMate II for long-term support," said D. Keith Grossman, president and CEO. "As we have indicated in the past, the experience to date with the device has been very positive. The level of adverse event trends recorded for this series of patients is significantly lower than what we've seen with our other, currently approved cardiac assist devices."
The HeartMate II is an implantable LVAS powered by a rotary pumping mechanism, weighs about 12 ounces and is roughly the size of a D-cell battery. It is designed to have a much longer functional life than other approved devices and to operate more simply and quietly, Thoratec said.
NICE supports dual-chamber pacing
In new medical guidance for England and Wales, the National Institute for Clinical Excellence (NICE; Watford, England) is promoting the expanded use of dual-chamber pacemakers for treating slow heart rhythms, or bradycardia, suffered by an estimated 100,000 UK residents.
NICE advises in its latest guidance that up to 90% of all pacemakers implanted to treat sick sinus syndrome and atrioventricular block the two primary causes of bradycardia should be dual-chamber devices delivering electrical impulses to both the right atrium and the right ventricle. Currently 60% of roughly 26,000 pacemakers implanted yearly in the UK are dual-chamber devices; the other 40% are single-chamber devices, which usually stimulate only the right ventricle.
"NICE rightly recognizes that dual-chamber pacemakers improve clinical outcomes cost-effectively for the treatment of bradycardia associated with sick sinus syndrome and atrioventricular block," said cardiologist Prof Richard Sutton, a consultant with the Royal Brompton Hospital (London). "This new guidance is based on an exhaustive review of the medical literature on the subject and should encourage specialists in heart rhythm disorders to implant a greater proportion of dual-chamber devices for patients suffering from this type of arrhythmia."
According to the guidance, NICE estimates that the cost to the NHS of implementing these recommendations will range from 8 million to 10 million per year, an investment that the assessment committee deemed cost-effective. "Dual-chamber pacemakers are well worth the extra cost," Sutton said. "The incremental cost-effectiveness ratio developed by NICE, at 8,500 per quality-adjusted life year, falls well within the generally accepted threshold of 30,000."
In addition to cost-effectiveness, the new guidance emphasizes the clinical benefits of dual-chamber pacing. For example, meta-analyses of various published studies considered by the committee showed a statistically significant reduction in atrial fibrillation, improvement in exercise capacity and improvement in quality of life, when dual-chamber pacing is compared to single-chamber pacing.
"NICE influences treatment decisions not just in the UK, but internationally as well," said Jenifer Eh-reth, MD, a health economist with Medtronic (Minneapolis). "So we are especially pleased with this guidance on dual-chamber pacing. Because of these recommendations, people with bradycardia starting with those in the UK now stand a better chance of getting a dual-chamber pacemaker when that is the most appropriate choice for them."
Results of one of the randomized clinical trials considered by NICE for the new guidance appeared in the 18 Jan. issue of the journal Circulation. The authors of the study, the Mode Selection in Sinus Node Dysfunction Trial (MOST), wrote: "For patients with sick sinus syndrome requiring pacing, dual-chamber pacing increases quality-adjusted life expectancy at a cost that is generally considered acceptable. Compared with [single-chamber] pacemakers, dual-chamber pacemakers in the MOST trial significantly reduced the rates of atrial fibrillation and hospitalization for heart failure and were associated with somewhat lower rates of stroke. This reduction in nonfatal events with dual-chamber pacemakers resulted in better quality of life observed during the trial on a number of measures and projected to an even greater extent beyond the trial because of the life expectancy of affected patients."
European distributors for SynX
Nanogen (San Diego), a developer of advanced diagnostic products, said that its SynX (Toronto) subsidiary has signed five new European distributors for its point-of-care products. The additional distribution agreements "significantly increase" SynX's coverage to 28 European nations, Nanogen said. The newly expanded network provides SynX with exposure to a potential customer base of more than 7,500 hospitals, 4,000 clinical laboratories and almost 11,000 cardiac specialists, as measured by the European Diagnostic Manufacturers Association.
All of SynX's European distributors were selected based on prior experience in the point-of-care device and equipment sector, as well as knowledge with cardiac and central nervous system diseases. The company said each partner will be responsible for the distribution and marketing of SynX's point-of-care tests and research-oriented products for congestive heart failure (CHF) and myocardial infarction. Expected to be commercially available this year, the CHF diagnostic product will measure NT-proBNP (N-terminal pro-hormone brain natriuretic peptide), which SynX describes as "a sensitive and specific biomarker for the diagnosis of congestive heart failure."
Licensing agreement signed with BGU
BioLineRx (Jerusalem) has signed a worldwide exclusive license agreement with Ben Gurion University (BGU) of the Negev through its business company, BGN Technologies, for an injectible scaffold that reduces damage after cardiac arrest. The post-heart attack treatment, dubbed BL-1040, "represents a breakthrough for the treatment of patients who have undergone heart attacks by helping to regenerate cardiac tissue," said CEO Morris Laster.
BioLineRx plans to develop the project through BioLine Innovations Jerusalem with funding it obtained from the Office of the Chief Scientist. The novel material, developed by Ben Gurion University biomedical engineers Smadar Cohen and Jonathan Leor, is a biodegradable polymer that, within minutes after direct injection into the damaged cardiac tissue, intercalates to form a molecular scaffold between heart cells and muscle fibers. The polymeric scaffold enhances the mechanical strength of the heart muscle and, in experimental heart attack models, was shown to improve outcome, resulting in improved return to normal function with reduced mortality.