A Medical Device Daily

ELA Medical (Le Plessis Robinson, France), a Sorin Group (Milan, Italy) company and a leader in the development of cardiac rhythm management (CRM) implantable and diagnostic systems, reported the European introduction of its Ovatio implantable cardioverter defibrillators (ICDs).

An ICD can prevent sudden cardiac arrest, the leading cause of death in Europe with an estimated 400,000 deaths annually. The new family of ICDs includes both dual-chamber (Ovatio DR) and single-chamber (Ovatio VR) models. ELA Medical said the Ovatio devices are the world's smallest ICDs, weighing 29 cc and measuring just 11 mm “thin,“ as the company characterizes it.

The “physiologically-shaped“ ICDs also offer 34 joules of maximum output, which ELA Medical said is useful for patients whose defibrillation threshold is particularly high and who may require more energy to terminate life-threatening arrhythmias.

The Ovatio ICD family also includes features dedicated both to pacing and arrhythmia management and advanced diagnostic features that offer what the company termed “significant patient benefits.“ The dual-chamber Ovatio DR includes AAIsafeR and PARAD+. AAIsafeR is ELA Medical's pacing mode, limiting unnecessary stimulation in the right ventricle, which the company said prevents onset and progression of heart failure.

With the AAIsafeR mode, the ICD continuously monitors a patient's intrinsic atrioventricular (AV) conduction and delivers ventricular pulses only when necessary. Studies have shown that AAIsafeR reduces the amount of ventricular pacing to less than 0.2% in ICD patients with intrinsic conduction, while according to the company, conventional dual-chamber ICDs “unnecessarily pace this patient population 50% of the time.“ The patient's AV conduction can fully be documented through detailed statistics and intracardiac EGMs.

Ovation DR's PARAD+ (P And R Arrhythmia Detection) ventricular arrhythmia detection software protect patients from inappropriate shocks that may result from misclassified supraventricular tachyarrhythmias (SVTs). ELA Medical said PARAD+ is “the most specific ventricular arrhythmia detection software available to patients worldwide today.“

While SVTs have been reported to trigger 55% to 69% of inappropriate shocks, the company said PARAD+ demonstrated a 99% overall specificity with out-of-the-box settings in a recently published study. Ovatio DR also is capable of detecting and treating the full spectrum of tachyarrhythmias through painless anti-tachycardia pacing (ATP). The device has the capability to terminate the slowest (100 bpm) as well as the fastest (up to 255 bpm) ventricular tachyarrhythmias.

The first post-launch Ovatio implant was performed at the Medizinische Klinik und Poliklinik (Heidelberg, Germany) Alexander Bauer, MD. Bauer said the implant procedure “went very smoothly. The shape and size of Ovatio VR made it easy to implant. Programming the ICD was also extremely simple.“

To make post-implant office visits faster, Ovatio ICDs are supported by a new programming software that the company said is 10 times faster than previous versions.

Andre-Michel Ballester, president of the Sorin Group's Cardiac Rhythm Management business unit, said the Ovatio introduction “reflects [our] drive to develop cutting-edge tachyarrhythmia management systems that are capable of respecting the heart's natural rhythm and bringing significant patient benefits.“ He added: “Although Ovatio ICDs are technologically sophisticated devices, they have been designed to simplify implant and follow-up procedures.“

Steen Solution gets CE mark

Vitrolife (Kungsbacka, Sweden) said it has obtained CE-mark approval for Steen Solution, a solution for functional testing and reconditioning of lungs outside the body before transplantation, which means that sales of the product in Europe can begin.

“The new method that has been developed means that the doctor can assess the suitability of the organ for donation after it has been taken from the donor in a way that was not possible previously. This in its turn means that the potential availability of organs that can be transplanted increases considerably,“ said CEO Magnus Nilsson.

Steen Solution enables heart-dead donors' lungs, or lungs from brain-dead patients that are initially assessed as “doubtful,“ to be tested outside the body for possible use.

The method was developed by Professor Stig Steen at University Hospital (Lund, Sweden) in collaboration with Vitrolife. “For people with severe lung disease, a group of patients that suffers greatly today, Steen Solution means a greater opportunity of receiving effective therapy,“ said Steen. Vitrolife said the new method for functional testing and preservation of lungs outside the body could in time lead to a five-fold to ten-fold increase in the number of lung transplantations carried out.

The company said it is the market leader within the area of lung preservation solutions with its Perfadex product, with more than 80% of all lung transplantations in the world performed using the product. Vitrolife has a U.S. subsidiary in Denver.

Anderson to head Vital Images Europe

Vital Images (Minneapolis), a provider of enterprise-wide advanced visualization and analysis solutions for use in clinical diagnosis and therapy planning, has named Stephen Andersen vice president of Vital Images Europe, effective March 1. He has served as vice president of engineering since January 2004.

Vital Images said it is in the process of selecting a site for its European office and expects to open the office by mid-year.

“Strong international sales growth, particularly through our distribution partnership with Toshiba Medical Systems, coupled with the opportunity to replicate the success we've had in selling and marketing throughout the healthcare enterprise in the U.S., are behind our decision to establish an office in Europe,“ said Jay Miller, president and CEO of Vital Images.

Through the first nine months of 2005, international sales contributed 17% of total company revenues, a 44% increase over the same year-earlier period.

“With more than 400 customers in Europe and a growing revenue stream, we have strong momentum in this market,“ said Andersen. “A European office will help us expand relationships with current customers and distribution partners, while establishing a direct sales presence for growing license and services revenue.“

Andersen joined Vital Images in 1999 as an engineering program manager and has held positions of increasing responsibility.

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