ELA Medical (Bad Nauheim, Germany), a developer of cardiac rhythm management implantable and diagnostic systems, reported the first implant early last month of its Ovatio DR, its new dual-chamber implantable cardioverter device (ICD) featuring the AAIsafeR 2 pacing mode. ELA said that the AAIsafeR 2 mode promotes the patient's intrinsic conduction by limiting unnecessary pacing to the ventricle to 0.1% in patients who have normal heart conduction1.
The first Ovatio DR device was implanted by cardiologist Johannes Sperzel, MD, department of cardiology at the Kerckhoff-Klinik (Bad Nauheim Germany), in a 51-year-old man with a history of myocardial infarction due to coronary artery disease. He suffers from episodes of polymorphic ventricular tachycardia and Sick Sinus Syndrome leading to symptomatic bradycardia.
Sperzel said: "Because Ovatio DR combines PARAD+, the most specific arrhythmia detection algorithm available today, with ELA's AAIsafeR 2, the only pacing mode capable of managing all three types of heart blocks, the device has the potential to become the gold-standard therapy for the vast majority of ICD patients. Ovatio DR answers important clinical needs for the physicians but also brings unprecedented benefits to the patient."
ELA said that recent studies have highlighted the importance of "not only maintaining normal AV synchrony, but also of avoiding unnecessary ventricular pacing. Excessively pacing the ventricle has been shown to be harmful to patients as it may increase the risk of mortality and hospital admissions due to heart failure." And it cited a recent study indicating that, in some patients paced more than 50% of the time via an ICD, there is increased risk of new or worsened heart failure and ventricular tachyarrhythmia.
AAIsafeR 2, ELA said, delivers ventricular pacing only when intrinsic cardiac impulses from the atrium are not conducted to the ventricle. "When intrinsic cardiac conduction resumes, AAIsafeR 2 automatically reverts back to physiological atrial-based pacing. AAIsafeR pacing technology has been available in Europe since September 2003 in ELA's Symphony pacemakers."
It reported another implant of an Ovatio DR in the UK on June 10 by Dr. Vince Paul, consultant in interventional cardiology and electrophysiology of St. Peter's Hospital (Chertsey).
ELA Medical said that the roll-out of the complete Ovatio ICD family is expected in 4Q05, together with its new generation of defibrillation leads.
Medtronic hails ESC's new HF guidelines
Medtronic Europe (Tolochenaz, Switzerland) cited its support for the new guidelines for the treatment of heart failure (HF) issued by the European Society of Cardiology (ESC; Sophia Antipolis, France). The company said that under the new ESC heart failure guidelines, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) have been designated Class I for indicated heart failure (HF) patients, which means they are recognized as standard-of-care treatments for many heart failure patients already on optimal medical therapy.
The guidelines stipulate that:
ICDs are recommended for indicated HF patients with reduced ejection fraction to decrease sudden cardiac arrest (SCA);
CRT is recommended in HF patients with reduced ejection fraction and cardiac dyssynchrony to improve symptoms and reduce mortality and hospitalizations.
"We are very pleased that the European Society of Cardiology is recommending routine use of defibrillators and CRT for heart failure patients with systolic dysfunction," said Peter Steinmann, vice president of Medtronic's Cardiac Rhythm Management business in Western Europe.
He added: "ICDs can correct deadly fast heart rhythms, the leading cause of mortality in heart failure patients. These implantable devices will protect thousands of patients from sudden cardiac death."
Defibrillation therapy is the only treatment option with the potential to reverse sudden cardiac arrest and thereby reduce mortality in HF patients who suffer a lethal heart rhythm.
"Based on several clinical trials, ICDs are now proven to effectively reduce sudden death among patients with heart failure and reduced systolic dysfunction," said Karl Swedberg, MD, of Sahlgrenska University Hospital at Ostra (Gotenborg, Sweden). "It is now up to the medical community to define which patients should be treated in clinical practice," he said.
Medtronic noted that extensive recent scientific evidence "demonstrates that ICDs prolong lives when used in conjunction with optimal drug therapy in indicated heart failure patients," including the Medtronic-supported Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which was published in the Jan. 20 issue of The New England Journal of Medicine, showing that ICDs increased survival by 23%.
It also said that results from the recent Medtronic-sponsored CARE-HF (Cardiac Resynchronization in Heart Failure) study, published in the April 14 issue of The New England Journal of Medicine, contributed to the ESC decision to designate CRT as Class I therapy for heart failure patients.
Zoll wins two international approvals
Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and software, reported receiving international regulatory approvals for two products: the AutoPulse Non-invasive Cardiac Support Pump and the Power Infuser from its Infusion Dynamics division.
The AutoPulse has received approval from Australia's Therapeutic Goods Administration, allowing for the sale and marketing of the AutoPulse to help treat sudden cardiac arrest in that country. The AutoPulse already has the CE mark, as well as regulatory approvals in Canada and New Zealand.
Zoll bills the AutoPulse Non-invasive Cardiac Support Pump as "revolutionary in its design and potential to offer better outcomes." As an adjunct to CPR, the AutoPulse does chest compressions that humans can't do, while moving much more blood, more effectively to the heart and brain. The device consists of a backboard and a simple LifeBand that fastens across a victim's chest, and it compresses the entire chest in a "hands-free" manner.
The Power Infuser, a miniature fluid resuscitation pump, has been granted approval by the Canadian Regulatory Agency, Health Canada Therapeutic Products Directorate, and it has the CE mark. To qualify for the CE mark, the Power Infuser was tested to international standards for electrical safety and electromagnetic compatibility. This testing is in addition to rigorous electromagnetic, climatic, altitude, vibration, and human-factor tests previously conducted by the U.S. Army and U.S. Air Force, which qualified the device for use in military aircraft, Zoll said.
"These additional approvals expand the markets where Zoll can sell its advanced resuscitation products and should help to continue the progress made in international sales last quarter," said Richard Packer, president and CEO. "Zoll remains focused on advancing the practice of resuscitation worldwide by offering a range of products that work together and help healthcare professionals save lives."
More CorAide implants completed
Arrow International (Reading, Pennsylvania) said last month that three additional patients had been implanted with the CorAide continuous flow left ventricular assist system (LVAS) as part of its European clinical trial of the device. The CorAide LVAS features a Portable Electronic Module (PEM) that responds automatically to the changing physiologic needs or demands of the patient, increasing or decreasing the pump's speed with corresponding changes in blood flow in response to a patient's level of activity.
Five patients have received CorAide implants since the clinical trial of the device was resumed in February, including one that was implanted at a new clinical trial center, Policlinico di San Matteo (Pavia, Italy). Physicians at the Diabetes and Heart Center (Bad Oeynhausen, Germany) have implanted four of the devices, reporting that the CorAide is performing well and allowing patients to recover rapidly from the operative procedure and begin ambulation. The first two CorAide patients have been discharged to their homes and have reached the endpoint of the study by exceeding 90 days on the device.
An additional trial center in Germany, Deutsches Herzzentrum Berlin, will begin screening patients following its completion of the CorAide training program later this month.
OAS device gets CE mark
Cardiovascular Systems (CSI; Minneapolis) said it has received the CE mark for its Orbital Atherectomy System (OAS) for treatment of peripheral artery disease, allowing its commercialization in Europe. The authorization was issued following a quality management system assessment visit by BSI Inc., a European Notified Body.
The Orbital Atherectomy Device utilizes a diamond-coated, eccentrically rotating cutting surface to ablate tissue. The company said the resulting particles are small enough to pass through capillaries and be eliminated by the body.
Noting that the approval represents "an important milestone for CSI as it works toward full worldwide commercialization of the OAS," Michael Kallok, CEO of Cardiovascular Systems, said, "We believe our OAS will become an important device that allows physicians to more easily treat peripheral artery disease."
CSI, which has previously received clearance to market the OAS to remove tissue-causing stenosis in synthetic A-V shunts, said it is working on obtaining FDA clearance for use of the device in peripheral vascular disease and approval for use in coronary arteries. The company said it expects to conduct initial market testing at a limited number of clinical sites before having a full commercial release of the product in the U.S. for the AV shunt indication.
Pronto catheter OK for sale in Japan
Vascular Solutions (Minneapolis) said early last month that its Japanese distribution partner, Nihon Kohden (Tokyo), reported the completion of import license and reimbursement notification for the sale of the firm's Pronto catheter in that country. Sales of the device to Nihon Kohden for distribution in Japan have begun. The Pronto catheter is designed for the mechanical aspiration removal of acute thrombus from the arterial system.
Howard Root, Vascular Solutions' CEO, said completion of the Japanese registration process was accomplished one quarter ahead of schedule.