A CDU

Biophan Europe (Castrop-Rauxel, Germany), the European subsidiary of Biophan Technologies (West Henrietta, New York), has reported a series of operational achievements for 2005.

Dr. Michael Friebe, CEO of Biophan Europe, highlighted the company’s progress in developing solutions that enable fully compatible MRI of medical devices such as heart valves, coronary and peripheral stents, and vena cava filters. “2005 was a year marked by substantial new accomplishments in meeting our biomedical mission and overall strategic objectives,” said Friebe. “Following our reorganization as a European subsidiary of Biophan Technologies in May, we have continued to make very encouraging progress on several major development fronts.

Biophan Europe is developing modification technologies to make a range of implanted devices clearly imageable with MRI systems. The company said its development program could “dramatically improve” interventional MRI and further enable minimally invasive surgical procedures.

Currently, many implantable and surgical devices comprised of metal are contraindicated for use with MRI, but Biophan Europe has developed a variety of resonant circuit technologies to enable MRI imaging techniques to look “inside” stents and other implants, and to enable MRI-guided implantation of the devices.

Developed under the stewardship of the company’s chief technology officer, Dr. Andreas Melzer, these capabilities, dubbed “potentially revolutionary” by Biophan, would make virtually any stent fully visible with MRI, accompanied by certain changes in device design or material and proprietary Amris technologies. Amris was the previous name of Biophan Europe.

Biophan Europe said it facilitated an exclusive license for Biophan Technologies with German biomedical researchers Dr. Arno B cker and Dr. Alexander Ruebben for their stent technology enabling accurate MRI in or around metallic stents. Together with the existing technologies already held by Biophan, including those obtained through the company’s acquisition of AMRIS, the license with B cker and Ruebben gives Biophan licensing ownership to what it said are “two of the most viable methods to create artifact-free images of stents and implants with MRI.”

Iitial studies in pigs have demonstrated the feasibility of MRI imageable stents as what Biophan characterized as “a solidly viable concept” and established that restenosis can be imaged using MRI. Based on these results, Biophan Europe said it intends to launch chronic animal studies, the next major preclinical testing phase, likely beginning in 2Q06.

The company said it also has further advanced a successful pre-clinical animal study collaboration related to MRI-vena cava filter imageability with a major strategic development partner, the University of Aachen (Aachen, Germany). The study is designed to show that the device would inherently be an effective filter and that this filter, as well as all other procedural tools used for the implantation procedure, would be fully compatible under MRI guidance, and would show the filter’s status under MRI. This first testing phase of the filter is expected to be completed in 1Q06.

Biophan Europe also completed pre-clinical animal trials this month demonstrating the conceptual feasibility and MRI imageability of a stent-based heart valve in a joint project spearheaded by Melzer with the National Institutes of Health (NIH; Bethesda, Maryland). It said that, based on those successful results, the first applications in which the heart valve will be implanted in human volunteers for further examination are expected to begin in 2006.

The company also said it had filed a number of “significant patent applications” to cover additional technologies related to development of an MRI-visible occluder, an implant designed to cure heart wall defects.

Michael Weiner, CEO of Biophan Technologies, said, “Biophan Europe’s research has generated 15 additions to Biophan’s extensive intellectual property portfolio, further strengthening our MRI technology leadership. The aquisition also brought new world-class scientific personnel and additional access to the European research community, where some of the most exciting research into MRI is being conducted.”

ELA introduces Ovatio ICD line

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, has 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. The recipient was an 82-year-old woman who suffered from ischemic cardiomyopathy. 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.”

France broadens Cypher reimbursement

The Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey) said the “excellent efficacy and safety data” for the company’s Cypher drug-eluting coronary stent is prompting what it terms “a significant change in French reimbursement” for the device.

The company said the Cypher DES and its next-generation Cypher Select are now the only drug-eluting stents in France to have reimbursement for in-stent restenosis for diabetic and non-diabetic patients, and for treatment of multiple lesions per procedure (one stent per artery, three stents maximum per patient) for both non-diabetic and diabetic patients.

The new reimbursement for the Cypher and Cypher Select is based on the French Health Ministry’s comprehensive review of the stent’s clinical evidence and health economic data, Cordis said.

The extension to include multiple lesions in a procedure will allow for up to three Cypher stents or Cypher Select stents to be used in a patient, including those with diabetes, who often are at a higher risk for restenosis (reblockage), the company said.

The incremental reimbursement took effect Dec. 20.

“We are extremely pleased that the French Ministry of Health has recognized the additional clinical value that the Cypher stent technology provides versus other drug-eluting stents,” said Bernard Zovighian, country manager in France for Cordis. “As more physicians choose our drug-eluting stent technology for this challenging patient population, hospitals and patients will continue to reap the clinical and economic benefit that have made the stents . . . choices in the treatment of coronary artery disease.”

In addition to the extended reimbursement, coverage also exists for the Cypher stent in France for a broad range of vessel diameters (2.5 mm to 3.5 mm) and lesion lengths.

CardioMag trades on AIM in London

CardioMag Imaging (Schenectady, New York), developer of a non-invasive Magnetocardiograph (MCG) heart function visualization product for the cardiology community, said that its common stock has been admitted to trading on the AIM Market of the London Stock Exchange.

In connection with its AIM admission, CardioMag raised about $9.3 million in gross proceeds, pursuant to a placing of its common shares through its advisor and broker, Williams de Broe.

The proceeds of the placement will be used for working capital, including expansion of the company’s international marketing efforts and U.S. manufacturing.

The market capitalization of CardioMag based on the issue price in the placement is about $50.9 million.

CardioMag’s MCG system integrates superconducting quantum interference devices with advanced software and hardware to form a new diagnostic technology providing functional information on the status of a patient’s heart. The MCG system measures the magnetic fields generated by the heart’s electrical activity, allowing a physician to identify abnormal cardiac conduction disturbances, including those created by the presence of coronary artery disease.

The company’s first marketed product is the CMI 2409 system, several of which already are installed in hospitals around the world. A more advanced system, the CMI 2436, is currently at the prototype stage.

The company also is developing a CMI Research system for use by medical research laboratories for animal studies of heart disease.

Enpath steerable sheath CE-marked

Enpath Medical (Plymouth, Minnesota) reported receiving CE-marking approval announced that it has received CE Mark approval for its steerable sheath, used to facilitate placement of interventional devices in the peripheral, coronary and neurovascular systems. The approval enables its distribution partner, Bard Electrophysiology, a division of C.R. Bard (Murray Hill, New Jersey), to launch the product in Europe for electrophysiology (EP) applications.

“With [FDA clearance] received in July, 2005, the European Union’s approval positions Enpath’s innovative steerable sheath for distribution in the two largest electrophysiology markets in the world,” said Jim Hartman, CEO and chairman of Enpath.

The Enpath steerable sheath features distal tip deflection for the precise placement of such devices as cardiac ablation catheters and peripheral stent delivery catheters. “The EP market is the first of a variety of clinical applications that can benefit from the use of our steerable sheaths,” Hartman said. “We are particularly excited by the potential for our proprietary steerable sheath technology to be used in the delivery of carotid artery stents and other peripheral vessel interventions, as well as for precision placement of implantable leads, and we are continuing to develop the device for these indications.”

Vasamed’s AcQtrac CE-marked

Vasamed (Minneapolis), a developer of non-invasive, hemodynamic assessment technology, reported receiving the CE mark for its new AcQtrac System, which provides real-time measurements of hemodynamic parameters that allow physicians to manage a range of cardiovascular patients.

FDA-cleared earlier this year, the AcQtrac relies on a graphical waveform that represents the mechanical function of the cardiovascular system and provides information to quickly assess conditions such as congestive heart failure or to monitor treatment outcomes such as those provided by drug therapy.

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