A CDU

St. Jude Medical (St. Paul, Minnesota) said it has received regulatory and reimbursement approvals from Japan’s Ministry of Health, Labor and Welfare for the EnSite system, a computer-based visualization and navigation tool used by physicians when treating patients with irregular heartbeats.

The system allows electrophysiologists to create computer-generated, 3-D models of their patients’ cardiac anatomy. After collecting and organizing electrical signal data from the inner surface of the heart, the system shows the location and movement of abnormal electrical impulses, helping physicians determine a treatment strategy. Such enhanced images were not possible with 2-D fluoroscopy.

“The EnSite system is the most advanced computer-based technology for mapping arrhythmias and navigating electrophysiology catheters in real time,” said Kazuo Ogino, president and CEO of Nihon Kohden (Tokyo), St. Jude’s EnSite system distributor in Japan.

He said that since market approval, the system has been used at a number of facilities in Japan, including Tsuchiura Kyodo, Yokohama Minato Red Cross, Kumamoto University, Nara Medical University, and the University of the Ryukyus. “This clearly indicates strong clinical utilization by Japanese doctors,” he said.

In the first procedures performed in Japan, electrophysiologists used the EnSite system and the EnSite Array non-contact catheter to diagnose and guide ablation therapy of patients with atypical atrial flutters and atrial fibrillation (AF).

“The introduction of EnSite in Japan will help physicians provide greater clinical value for Japanese patients by accurately diagnosing the origin of arrhythmias quickly and safely,” said Joseph McCullough, president of St. Jude Medical’s International Division. “These capabilities are a critical element of effective electrophysiology procedures.”

St. Jude also said it received European CE-mark approval of its newest devices for treating patients with potentially lethal heart arrhythmias and heart failure.

The Epic II ICD (implantable cardioverter defibrillator) and the Epic II HF CRT-D (cardiac resynchronization therapy defibrillator) feature faster device data transmission to speed patient follow-up exams and a “patient notifier” that gently vibrates to alert patients of critical changes in device function, the company said.

The first European implant of the Epic II VR was performed by Johannes Holzmeister, MD, and Firat Duru, MD, professor and director of pacing and electrophysiology at University Hospital (Zurich, Switzerland).

“Telemetry in the new Epic II ICD is noticeably faster, particularly when downloading stored electrograms,” said Duru. “The device also includes the first vibration-based patient notifier. Unlike other products on the market that use an audible notifier, the Epic II device may be particularly helpful for patients who have trouble hearing.”

St. Jude said the Epic II devices, which received FDA approval last month, include:

• Faster telemetry, designed to speed data from the ICD to the system programmer at a rate up to five times faster than previous St. Jude Medical devices.
• The industry’s first non-audio alert, which vibrates to notify patients of critical changes in device performance so they can contact their clinician for follow-up care.
• SenseAbility technology, a St. Jude technology designed to protect against inappropriate ICD shocks.
• AutoIntrinsic Conduction Search, intended to promote more natural heart function and minimize ventricular pacing. Studies have shown that excessive ventricular pacing may contribute to heart failure in some patients.
• DeFT Response(TM) technology designed to help physicians manage patients who require higher levels of defibrillation.

“The Epic II devices offer important benefits to patients and their physicians, including an innovative patient notification feature, advanced diagnostics and the ability to conduct faster follow-up exams,” said Eric Fain, MD, executive vice president of development and clinical/regulatory affairs for St. Jude’s Cardiac Rhythm Management Division. “These devices, along with the recently launched Merlin Patient Care System, provide state-of-the-art technology to European physicians as they manage the complexities of heart failure.”

St. Jude also reported CE-mark approval for two new electrophysiology (EP) products – the Therapy Cool Path all-braided ablation catheter and the IBI-1400-CV Internal Cardioversion system.

The announcement was made at Cardiostim 2006, a biannual meeting of cardiac specialists held in mid-June in Nice, France.

St. Jude Medical presented results from its QuickOpt Optimization clinical study at Cardiostim’s late-breaking clinical trials session and sponsored several symposia during the international congress.

The Therapy Cool Path all-braided ablation catheter delivers radio frequency energy to specific cardiac tissue, creating lesions that interrupt the abnormal electrical signals that contribute to heart arrhythmias. The catheter’s tip cools tissue as energy is applied, helping physicians create deeper, more effective lesions. Its all-braided shaft gives physicians more control and precision in maneuvering and placing the catheter.

The IBI-1400-CV Internal Cardioversion system helps physicians provide cardioversion (restoring a patient’s normal heart rhythm) –via catheter –quickly and simply during EP procedures with lower voltage than is necessary for successful external cardioversion, St. Jude said. Physicians can flip a switch to change the catheter from a diagnostic tool to providing cardioversion.

France okays reimbursement for Endeavor

Medtronic (Minneapolis) reported receiving reimbursement approval in France for the Endeavor drug-eluting coronary stent (DES) system. The company said the stent would be available June 21 to public and private hospitals throughout France, providing physicians and patients with another option for the treatment of coronary artery disease in one of the largest DES markets in Europe. About 165,000 stents are used in France each year, some 55% of them drug-coated stents.

Made of a cobalt alloy, the Endeavor stent has a unique modular architecture designed to enhance deliverability. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an ideal healing response, the company said.

Patrick Mackin, vice president of Medtronic’s vascular business in Western Europe, said, “The Endeavor stent system provides an excellent combination of deliverability, effectiveness and safety, with long-term clinical results that clearly show it to be an ideal choice for physicians considering a drug-eluting stent for their patients.”

Medtronic presented data at last month’s Paris Course on Revascularization that provided compelling clinical evidence demonstrating the long-term safety and efficacy of the Endeavor. Three-year and two-year results from the ENDEAVOR I and ENDEAVOR II clinical trials demonstrated low rates of repeat procedures, target lesion revascularization, as well as low rates of major adverse clinical events (MACE) such as death and myocardial infarction.

No late stent thrombosis was reported in either of the two trials. Late stent thrombosis is the formation of blood clots that potentially can lead to heart attacks or death. In all of its Endeavor clinical trials to date, there have been no reported cases of late stent thrombosis in more than 1,300 patients who have been followed for at least one year.

“The clinical data for the Endeavor stent is strong, with long-term safety and efficacy results that make it a welcome addition to the drug-eluting stent market in France,” said Jean Fajadet, MD, of Clinique Pasteur Unite de Cardiologie Interventionnelle (Toulouse, France) and a co-principal investigator of the ENDEAVOR II trial. “The safety record is very impressive, with no late stent thrombosis. Almost 90% of the patients who received an Endeavor stent are MACE free and almost 94% required no f! further treatment or revascularization.”

The Endeavor stent has been commercially available in most of Europe and in many other international markets since August 2005.

Enrollment starts in Sorin’s BITAC study

Sorin Group’s (Milan, Italy) Cardiac Rhythm Management business unit reported the first patient enrollment in the BITAC (BIventricular TAchycardias Outcome in CRT-D Patients) clinical study.

The purpose of the BITAC study is to assess the incidence of slow ventricular tachycardias (VTs) in heart failure patients implanted with cardiac resynchronization therapy (CRT) devices, as well as the clinical relevance of treating slow VTs during a two-year follow-up period. The principal investigator for the study is Alexander Bauer, MD, of University Hospital of Heidelberg (Heidelberg, Germany).

The study will enroll more than 400 patients across Europe, with enrollment anticipated to be completed by the end of 2007.

The first patients to be enrolled were implanted with Sorin Group’s Ovatio CRT, the world’s smallest CRT-D (cardiac resynchronization therapy plus defibrillator). The device includes the Brady Tachy Overlap function, which allows the setting of low-rate detection zones for slow VTs, while still allowing pacing and delivery of resynchronization therapy during patient exercise.

The implants were performed at the St. Adolf-Stift Hospital (Reinbek, Germany) by Dr. Herbert Nagele, MD, senior assistant medical director, and at the Hospital Fernando Da Fonseca (Amadora, Portugal) by Francisco Madeira, MD, assistant cardiologist and electrophysiologist, and by Pedro Cunha, MD, assistant cardiologist in the pacing and arrhythmia unit.

Madeira commented: “This important study will give physicians better insight into the management of slow VTs for heart failure patients. It will be of particular interest because, until today, technology limitations restricted our ability to monitor and treat slow VTs in HF patients without compromising the delivery of cardiac resynchronization therapy.”

Sorin said sub-analysis of studies performed in a general implantable cardioverter defibrillator (ICD) population has shown that slow VTs (lower than 150 beats per minute) are more prevalent and have more serious consequences in those patients with depressed ventricular function.

The BITAC study specifically aims to address the clinical relevance of slow VTs in a heart failure population and to offer physicians better insight on how to improve the management of ventricular arrhythmias in CRT-D patients.

Patients included in the multi-center study have advanced heart failure and are at increased risk of sudden cardiac death (SCD). Heart failure affects about 10 million Europeans. CRT devices deliver pacing impulses to the heart muscle to resynchronize the contractions of the ventricles and thus increase cardiac pump efficiency.

Since heart failure patients are up to nine times more likely to suffer SCD than the general population, combining CRT with an implantable defibrillator can be life-saving for these patients.

Cardiac marker market on growth curve in Europe

The market for cardiac markers used in primary care is experiencing a tremendous rate of growth across Europe due to their precise diagnostic properties. With rapid turn-around times, these cardiac markers are seen enabling cost reductions and improved patient outcomes.

International consulting firm Frost & Sullivan says that over the next three to four years, cardiac markers will be implemented more effectively in primary care to support decreased bed occupancy, hospital costs and physician time.

Frost & Sullivan said that the European primary care cardiac diagnostics market had revenues of $50.3 million in 2005 and estimates this to reach $149.4 million in 2012.

“Cardiac point-of-care testing (POCT) offers many benefits for primary care, particularly in improving turnaround results and in allowing earlier and more appropriate treatment,” said Dr. Fiona Rahman, Frost & Sullivan team leader of clinical diagnostics.

She added: “POCT can better satisfy customer needs with the introduction of new cardiac markers; in addition to boosting patient confidence with on-the-spot tests that improve disease diagnosis and monitoring, these diagnostics also enable the implementation of programs designed to prevent the onset of diseases.”

Cardiologists have developed the market by switching from conventional methods of heart disease diagnosis to these markers. The use of cardiac diagnostic tests in primary care is poised to grow due to the introduction of point-of-care technologies.

“These cardiac markers will give more valuable indications during emergencies towards determining appropriate treatments and the level of risk of a heart attack,” said Rahman. “The rapid turnaround times of cardiac markers will reduce costs and improve the treatment of patients admitted with chest pain.”

She said that although the science behind cardiac assessment is growing, the cardiology community still requires further education and training on the advantages of these risk markers. Rahman said medical communities in the UK and France in particular are hesitant to adopt new methods of diagnosing, treating and managing patients without adequate corroboration that they will make significantly enhanced contributions to patient well-being and cost savings.

“Physicians are sceptical about adopting novel markers and continue to rely on tried and tested methods of diagnosis, which are cheaper and do not require validation and scientific support,” she said. “These end users are reluctant to experiment with expensive markers, which are essential to complement more traditional diagnostic methods.”

In its report, “European Utilization of Cardiac Markers in Primary Care,” Frost & Sullivan said the challenge for manufacturers will be to promote cost-effective cardiac diagnostics markers as well as to encourage end users to trial and adopt risk tests as routine diagnosis.

Ultimately, the report said, increasing awareness about the benefits of using cardiac markers in primary care will benefit both healthcare providers and patients. Informed patients who understand the concept of cardiac markers are more likely to request the most current and novel markers available.

UK program uses LDX System

Cholestech (Hayward, California) said that Flora pro.activ, the UK’s leading cholesterol-lowering brand, has selected the Cholestech LDX System, a cholesterol monitoring tool, as part of the “Test the Nation” program. This is the second national heart health initiative that has used the Cholestech LDX System, as the Swiss Heart Foundation submitted results of its national screening program to the Swiss Health Ministry earlier this year.

The Test the Nation program is being run by Flora pro.activ, in association with H.E.A.R.T. UK (the Hyperlipidaemia Education and Research Trust). The program aims to provide the necessary information that will encourage people to find out what shape their heart is in and take responsibility for their heart health.

The campaign kicked off at the start of April and takes place at city centers, supermarkets and major events. Over a four-month period, Unilever is offering free heart health checks with fully qualified nurses and expert advice on diet and lifestyle. In addition to free blood pressure and cholesterol testing with a qualified nurse, everyone tested will receive a Complete Guide to Heart Health.

The cholesterol screening is being conducted using the Cholestech LDX System, which generates comprehensive lab-accurate results in minutes. Using a simple finger-stick, the LDX System can measure cholesterol, glucose and liver enzymes, and now, high-sensitivity C-reactive protein. This enhances the ability to quickly identify patients with risk factors for heart disease, enabling physicians to focus on getting patients on the right treatment sooner and making sure they stay on the right therapeutic mix.

Cholestech also said that it and its Mexican partner, Nutritional Science and Technology (NST; Mexico City), have entered a contract with the Mexican Ministry of Communication and Transportation to supply the Cholestech LDX System, a cholesterol monitoring tool, for the Direccion General de Proteccion y Medicina Preventiva en el Transporte (DGPMPT).

As part of the agreement, the DGPMPT will initially acquire 42 LDX Systems and 25,000 lipid test cassettes that will be used in the national health and wellness initiative targeting commercial vehicle operators.

DGPMPT regulates the safe movement of materials and people throughout Mexico, including the licensing of operators of taxis, buses, airplanes, railroad, ships and tractor trailers. Every year, more than 100,000 transportation workers must complete physical examinations to ensure that their health complies with the ministry’s standards for job qualification.

Based on the results of a six-month pilot, the ministry determined that the adoption of the Cholestech LDX System was the most appropriate and cost effective method of providing cardiovascular screening in more than 40 health centers throughout Mexico.

Using a small drop of blood, the Cholestech LDX system measures cholesterol, glucose, liver enzymes, ALT and AST, and now, high sensitivity C-reactive protein (hs-CRP) at the point of care.