A CDU

Sorin Group’s (Milan, Italy) Cardiac Rhythm Management (CRM) business unit reported at the Venice Arrhythmias 2005 Congress the European launch of two new cardiac resynchronization therapy (CRT) products. They are the Ovatio CRT defibrillator and NewLiving CHF pacemaker (CRT-P) for the treatment of heart failure patients. The company said Ovatio “ensures delivery of resynchronization therapy at higher pacing rates while providing anti-tachycardia protection against slow ventricular tachycardias [VTs].”

Sorin Group CRM said the Ovatio and NewLiving devices are “the first to provide cardiac resynchronization therapy that delivers optimal hemodynamic performance.” Noting that the heart “is seen as a blood pump as well as a ticking clock,” the company said that information on the hemodynamic status of a patient “complements that on rhythm to achieve customized diagnosis and treatment.”

At 30 cc, Ovatio is the smallest CRT-D device available on the market, according to Sorin Group CRM. The device is indicated in heart failure patients who might be at risk for sudden cardiac death (SCD), designed to resynchronize ventricular contractions and deliver defibrillation support when necessary.

The company said heart failure affects 10 million Europeans and more than 22 million people worldwide and is expected to almost triple by 2020. The European Society of Cardiology (ESC; Sophia Antipolis, France) says that about 40% of heart failure patients could benefit from CRT-Ds and CRT-Ps. Under new 2005 ESC heart failure guidelines, cardiac resynchronization devices have been designated as standard-of-care treatment for heart failure patients already on optimal medical therapy.

Sorin Group CRM said the Ovatio defibrillator addresses the challenge of ensuring resynchronization of slow ventricular tachycardias at exercising rates with its Brady-Tachy Overlap (BTOTM) zone, which accurately discriminates VTs as slow as 100 beats per minute while maintaining 100% cardiac resynchronization support in the same rate range. It said the device offers a full range of options to optimize CRT and to treat VTs between 100 and 255 beats per minute.

Ovatio also includes PARAD+, which the company said is the most specific ventricular arrhythmia detection software available to patients worldwide today. It said PARAD+ has been shown to decrease a patient’s individual risk of receiving inappropriate shocks due to atrial fibrillation to just 0.3%.

Dr. John Morgan, of the Wessex Cardiac Unit at Southampton General Hospital (Southampton, UK), said he believes that “Brady-Tachy Overlap will set the standard for flexibility of therapies in CRT-D patients.”

As a complement to its CRT systems and left ventricular over-the-wire and stylet-driven SITUS lead system, Sorin Group also is introducing its latest-generation Isoline defibrillation leads. The company said the Isoline leads combine carbon tip and steroid elution with dual-coil technology.

The NewLiving system includes a dedicated right ventricular pacing and sensing lead that also integrates Sorin’s Peak Endocardial Acceleration (PEA) contractility sensor. The company said continuous monitoring of PEA allows the device to “automatically optimize the timing and activation sequence of the heart chambers to deliver maximum hemodynamic benefit to the patient.”

Japan launch of Multi-Link Vision RX stent

Guidant (Indianapolis) has launched its Multi-Link Vision RX Coronary Stent System in Japan following receipt of regulatory and reimbursement approvals. The rapid-exchange Multi-Link Vision RX system is part of Guidant’s class of cobalt chromium stents. The company said cobalt chromium “is stronger and more radiopaque than stainless steel, giving cobalt chromium stents thinner struts without compromising visibility.” The result, it said, “is a lower profile and more deliverable stent that enables physicians to access challenging coronary lesions.”

“The Multi-Link Vision RX Stent System integrates the features of a cobalt chromium stent with Guidant’s rapid-exchange delivery system. With its thin struts and superb deliverability, the Vision RX Stent System has consistently demonstrated excellent acute performance and long-term clinical outcomes,” said John Capek, PhD, president of the company’s Vascular Intervention business.

Japan’s Ministry of Health, Labor and Welfare ap-proved the Multi-Link Vision RX Coronary Stent System in 3.0 mm to 4.0 mm diameters and 8 mm to 28 mm lengths in coronary vessels. The Multi-Link Vision Registry has demonstrated positive clinical results, with 1.9% clinically driven target lesion revascularization and a 15.7% binary restenosis rate at six months.

Greg Davis, president of Guidant Japan, said, “The Multi-Link Vision RX offers excellent clinical results for the treatment of coronary artery disease. This breakthrough cobalt chromium stent is a welcome new option for physicians in Japan.”

Guidant plans to use the cobalt chromium stent technology in future drug-eluting stent programs. The company recently initiated SPIRIT II AND SPIRIT III, large-scale pivotal clinical trials evaluating the safety and efficacy of its drug-eluting stent system.

These prospective, randomized, single-blind trials compare Xience V, an everolimus-eluting stent system using the Multi-Link Vision stent system platform, vs. the Taxus Express2 paclitaxel-eluting coronary stent system from Boston Scientific (Natick, Massachusetts).

Guidant received acceptance from the MHLW in September to begin patient enrollment in the SPIRIT III Japan Registry.

Mitral valve version of Perimount Magna

Edwards Lifesciences (Irvine, California), a major global maker of heart valves, reported the European launch of its new Carpentier-Edwards Perimount Magna heart valve for use in replacing patients’ mitral valves. Edwards said the technology, which features the company’s proprietary bovine pericardial tissue, represents the latest technological advancements for the mitral position, reflecting what it described as “more than 20 years of clinical experience and innovative design features.”

Anita Bessler, corporate vice president of global franchise management, said that unlike some tissue mitral valves that actually are porcine aortic valves that have been reversed to fit into the mitral position, the Perimount Magna valves “are bioengineered specifically to address the mitral valve’s unique anatomical structure and rigorous conditions.”

Bessler said the new valve incorporates the best features of the company’s Perimount Magna aortic heart valve into a new therapy that addresses what she described as “the mitral valve’s unique durability, ease of use and hemodynamic performance requirements.”

The Perimount Magna mitral valve features a low profile, saddle shape and asymmetrical design that Edwards said were developed to facilitate proper positioning and optimize blood flow. “The valve’s bovine pericardial tissue leaflets were designed to endure the particularly stressful pressures associated with the operation of the mitral valve,” the company said in a statement.

The valve also features the new Carpentier-Edwards ThermaFix advanced tissue process, which Edwards said was developed “to further mitigate tissue heart valve leaflet calcification, one of the primary causes of tissue valve deterioration.”

Ruediger Lange, MD, director of the German Heart Center’s (Munich, Germany) department of cardiovascular surgery, who performed the first surgical implant of the Perimount Magna mitral replacement valve, said the development of a replacement therapy that can bring the benefits of the Perimount Magna aortic valve to the mitral position “will provide greater confidence for physicians to offer mitral pericardial valves to younger patients who wish to avoid the lifelong blood-thinning therapy associated with mechanical heart valves.

He noted that his surgical team had used both the Magna aortic and mitral valves in a double-valve replacement procedure because of their durability. “After implantation, we were extremely impressed with the Magna mitral valve’s low profile, which may further enhance both blood flow and durability.”

Edwards introduced the Perimount Magna mitral valve at the annual meeting of the European Association for Cardio-thoracic Surgery (EACTS; Windsor, UK) in Barcelona, Spain.

The company also has submitted regulatory filings FDA, and said it believes that U.S. sales of the Magna mitral valve could begin in 2006.

Estech reports clearances of Cobra products

Estech (Danville, California) said at the European Association of Cardio-thoracic Surgery (EACTS; Windsor, UK) conference that it has received European and U.S. regulatory clearances to market Estech Cobra products that are used surgically to treat atrial fibrillation (AF). The Cobra products are the first ablation devices available that have received clearance to be marketed specifically for AF, Estech said.

Ray Bertolero, company vice president and co-founder, said at the EACTS meeting: “The new Cobra devices will offer new treatment options to a significant number of current AF patients.”

The Cobra, Cobra Adhere XL and Cobra Bipolar Pacing Probe have recently received FDA 510(k) marketing clearance, and the Cobra Adhere Surgical System has received the CE mark with an indication for treatment of AF.

The Cobra Adhere system is used by surgeons to make lesions on the heart that block the electrical impulses that cause AF. The Cobra Adhere XL will enable a minimally invasive technique to treat AF. The Cobra Bipolar Pacing Probe is, according to Estech, the first radio frequency ablation accessory in the U.S. and Europe intended for the treatment of cardiac arrhythmias. It provides a means for immediately evaluating the effectiveness of AF treatment procedures.

Cobra technology uses an intelligent temperature-based system that provides both optimal and reproducible results by regulating the RF energy.

St. Jude’s Riata ICD leads okayed in Japan

St. Jude Medical (St. Paul, Minnesota) reported receiving regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for the Riata family of implantable cardioverter defibrillator (ICD) leads. The leads, with diameters as small as 6.7 Fr, rank among the world’s thinnest, the company said. They are the first St. Jude high-voltage leads available in Japan.

“Riata leads provide an excellent complement to the premiere Epic+ and Atlas+ ICD families introduced in Japan last month,” said Paul Bond, president of Getz Brothers Co. (Tokyo), a St. Jude Medical company. In addition to Getz Brothers, the leads will be distributed in Japan through Fukuda Denshi.