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Eucomed (Brussels, Belgium), the European medical technology industry association, said it is urging the Japanese government to reform what it calls the “burdensome and unpredictable” regulatory and price-setting processes that delay patient access to advanced medical technology. Eucomed says that Japanese patients may have to wait up to five years longer than European patients to benefit from innovative therapies and products. In particular, the association is calling for the reform of the Foreign Average Pricing (FAP) setting reimbursement prices for certain categories of medical devices. This system creates disincentives to invest into medical technology in Japan.

FAP is based on comparisons with prices of similar products in the U.S. and selected European countries (Germany, France, and the UK) without taking into account, Eucomed says, the differences in local conditions and costs for manufacturers. Most of the medical devices, both in volume and by category, currently subject to FAP are designed and produced outside Japan, many of them in Europe.

Eucomed says it is concerned about how comparison prices are gathered, analyzed and verified, and how comparisons will be made between prices for different products from several manufacturers in the same functional category. Additionally, it says that because of long delays in the approval of new medical devices in Japan, many products are no longer marketed in the comparator countries in Europe, thus making price comparisons are problematic and misleading.

From April 2002 to March 2006, Eucomed estimates that reimbursement price decreases in Japan will have cost industry about 330 billion yen (EUR 2.5 billion).

Eucomed says that compared to other markets, Japan retains a complex multi-layered distribution system and many inefficient small hospitals that perform procedures so infrequently they do not develop or retain the necessary expertise. These factors lead to expensive ongoing technical support from manufacturers and importers independent of the size of the hospital. In addition, the costs to manufacturers and importers of compliance with Japan’s regulations are large and significantly higher than in other parts of the world.

On another subject, Eucomed said later in the month that it “welcomes” the publication by the European Commission (EC) of its “Proposal for a Regulation on Advanced Therapies,” which lays down what the organization said are “long-awaited harmonized rules” for the approval and marketing of human tissue-engineered products in the European Union (EU).

Eucomed said that many of such products are not available to patients today because of the absence of EU-wide legislation. The European Commission’s Scientific Committee on Medicinal Products and Medical Devices has defined tissue engineering as “the regeneration of biological tissue through the use of cells, with the aid of supporting structures and/or biomolecules.” The biodegradable structure can be made of synthetic or natural materials, and the cells can be derived from the patient (autologous cells) or from a donor (allogeneic).

The industry association said the potential global market for this sector has been estimated at up to EUR 400 billion. According to Eucomed, which represents what it termed “the majority of companies active in human tissue engineering in the EU,” a large share of this market would become accessible to the EU if an appropriate harmonized framework is put in place.

Eucomed’s statement cited human tissue engineering as “an exciting and rapidly expanding sector characterized by several ‘convergent technologies’ which will revolutionize patient care, enabling the regeneration of damaged tissues and organs instead of their replacement or repair by traditional surgical procedures.” It said, for example, that severe life-threatening burns and chronic wounds suffered by diabetic patients already can be treated via tissue-engineering technology. Tissue-engineered skin substitutes are widely used for treating severe burns and chronic wounds, for example. For Germany alone, it is estimated that 2 to 3 million people suffer from chronic wounds.

Another area where tissue-engineering technologies already are in use is regeneration of cartilage to treat traumatic knee joint injuries. Research is being carried out to treat other joint cartilage defects such as arthritis and intervertebral disc damage. Tissue-engineered bone products also are being developed for the treatment of bone fractures, osteoporosis and bone tumors. According to Eucomed, “many patients have not been able to access this technology in their country because of the absence of EU-wide rules.”

It noted that “more sophisticated” products are in the pipeline and will soon help to treat various conditions related to cardiovascular disease, for example. Tissue-engineered heart valves will offer new benefits to patients, and the development of tissue-engineered blood vessels aims at replacing damaged or blocked natural blood vessels. Research also is being conducted in the field of heart muscle tissue regeneration, as well as regeneration of tissues of the nervous system to treat neurodegenerative diseases.

In the future, it said human tissue engineering would help overcome the scarcity of donor organs by regenerating entire organs, with research already being undertaken to construct a bioartificial heart and a bioartificial liver.

Maurice Wagner, director general of the association, said Eucomed would analyze the EC’s proposal in detail. “We need to be sure it fully takes account of the specific nature of human tissue-engineered products which are neither pharmaceutical products nor medical devices. We also need to check whether it is in line with the approaches adopted in other parts of the world such as the U.S. and whether it can make the EU attractive to foreign investment.”

CE mark for HeartMate II

Thoratec (Pleasanton, California) reported last month that it had won CE-marking for its HeartMate II Left Ventricular Assist System (LVAS). The company said it expects to initiate product sales activities in the market before the end of the year. The HeartMate II is a next-generation cardiac assist device designed to provide long-term support for patients in advanced-stage heart failure. The device currently is undergoing a Phase II pivotal clinical trial in the U.S. for both destination therapy (DT) and bridge-to-transplantation (BTT).

The HeartMate II is a continuous flow device designed to provide long-term cardiac support for patients who are in advanced-stage heart failure. An implantable LVAS powered by a rotary pumping mechanism, it is approximately one-fifth the size of the company’s current FDA approved HeartMate XVE device. The HeartMate II is designed to have a much longer functional life than currently approved pulsatile devices and to operate more simply and quietly.

Keith Grossman, president and CEO of Thoratec, said that CE-marking was achieved based on a submission made seven months earlier. “It is the result of the first rigorous regulatory assessment of our next-generation technology and provides further validation for the HeartMate II’s performance and its very positive phase I clinical trial experience,”

The regulatory application for European approval was based on data from the first 20 patients implanted in the company’s Phase I U.S. trial and in a European study. Patients enrolled in the entire pilot study population accounted for more than 7,900 days of cumulative support, with each supported from one day to 717 days.

As of Oct. 21, 153 patients had been enrolled in the worldwide HeartMate II trial experience, including 102 patients in Thoratec’s U.S. Phase II pivotal trial. This includes 52 in the BTT arm and 50 in the DT arm of the Phase II trial. Excluding control arm patients, 143 patients have now been implanted with the HeartMate II.

“The HeartMate II has generated a high level of interest among clinicians in Europe due to the positive patient experience and ease of implant. With this approval, we now have four cardiac assist devices approved for sale in Europe, enabling us to offer clinicians both short- and long-term treatment options for patients with heart failure,” said Jeffrey Nelson, president of Thoratec’s cardiovascular division.

WorldHeart eyes start of rotary VAD clinicals

WorldHeart (Oakland, California) said it has been notified by the Ethics Committee of St. Luke’s Hospital (Thessaloniki, Greece) of its approval to proceed with a clinical feasibility study involving the first human use of WorldHeart’s rotary ventricular assist device (VAD). The feasibility study will primarily evaluate the hemodynamic performance of WorldHeart’s next-generation rotary system. The trial is expected to begin early next year, pending completion of pre-clinical testing and acceptance of the clinical investigation application by the Greek Ministry of Health.

“This is an important step in bringing our next-generation rotary system into clinical use,” said Jal Jassawalla, WorldHeart’s president and CEO. He said the company “continue[s] to be on plan toward our objective of starting initial human use of our rotary system in early 2006.”

Dr. Antonis Pitsis, cardiac surgeon and director of the Thessaloniki Heart Institute at St. Luke’s Hospital, who will be the site’s principal clinical investigator, said, “We are looking forward to the first clinical use of this next-generation implantable blood pump, which holds the promise of high durability and hemodynamic performance. Our team has been trained in the use of this device and is ready to initiate this important clinical project.”

WorldHeart said its European team would provide technical and clinical support for the feasibility study. “We are excited to approach the first human use of our magnetically levitated, next-generation centrifugal rotary VAD, said Pratap Khanwilkar, PhD, vice president, rotary systems and business development.

He said WorldHeart has carried forward a longstanding relationship with the Greek center, originally established by MedQuest, a company acquired by WorldHeart earlier this year.

Khanwilkar said the upcoming study, combined with the ongoing development of the next-generation Novacor II pulsatile pump, results in WorldHeart being the only company working to commercialize both next-generation rotary and pulsatile pumps.

The WorldHeart rotary VAD is a continuous flow pump that uses what the company calls “the simplest magnetic levitation design” to fully suspend the spinning pump rotor, its only moving part, inside a compact housing. The centrifugal pump and integrated motor do not have any mechanical bearings, shafts or seals, nor does it depend on blood to provide suspension forces.

The Novacor LVAS, a pump implanted alongside the patient’s own heart to take over a large portion of the workload of the natural heart, supports end-stage heart failure patients. It is an electrically powered, pulsatile flow device with more than 20 years of clinical use. To date, more than 1,600 patients have been supported with the Novacor, with more than 600 patient-years of experience and no deaths attributed to device failure. The Novacor LVAS is commercially approved as a bridge to transplantation in the U.S. and Canada, while in Europe, the device has unrestricted approval for use as an alternative to transplantation, a bridge to transplantation and to support patients who may have an ability to recover the use of their natural heart. In Japan, the device is commercially approved for use in cardiac patients at risk of imminent death from non-reversible left ventricular failure for which there is no alternative except heart transplantation.

NMT reorganizes European operations

NMT Medical (Boston) reported the reorganization of its European operations in anticipation of the final results from its MIST (Migraine Intervention with STARFlex Technology) clinical study, which are expected to be available in late March or early April 2006. As part of the initiative, the company is promoting Brad Ryno to vice president, worldwide sales and Geoff Fournie to vice president, clinical development, Europe. Ryno rejoined NMT Medical in June 2004 as director, commercial development, North America after having spent three years with the company’s former neurosciences division. Fournie joined NMT in June 2002 as director, commercial development, Europe.

John Ahern, president and CEO, said, “We are anticipating positive results from our MIST clinical trial in the UK. In advance of these results, the company has made the strategic decision to increase its investment now in what we view as our next emerging marketplace – PFO closure for migraine headache treatment in Europe.” Under the new organizational structure, Ryno will have responsibility for the worldwide sales group currently covering Europe, the U.S., Canada and Mexico. He will be responsible for expanding the current European sales organization to create and respond to an anticipated increase in demand for PFO closure related to the company’s expectation of a positive MIST outcome in early 2006.

Fournie, who was instrumental in facilitating the MIST, BEST (BioSTAR Evaluation STudy) and MIST III studies in Europe, will be given an expanded role to also include procedure reimbursement, patient referral and other initiatives to build acceptance of PFO closure procedures with NMT Medical’s STARFlex and BioSTAR technologies.

NMT Medical is investigating the potential connection between a common cardiac defect called a patent foramen ovale (PFO) and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). A PFO can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 20,000 PFOs have been closed globally with the company’s minimally invasive, catheter-based implant technology.

CE mark for Victory pacemakers

St. Jude Medical (St. Paul, Minnesota) has received CE-mark approval for its Victory pacemaker family, which allows for sale of the products in European Union (EU) countries. St. Jude said the newly approved pacemaker line is expected to be released broadly in Europe in 1Q06. The company said the Victory pacemakers offer “an important combination of features,” including what it characterized as “optimized settings to save time at implant,” VIP (Ventricular Intrinsic Preference) technology to minimize ventricular pacing, a FastPath summary screen to speed follow-up exams, and advanced technologies to extend the life of the device in patients.

Wolfgang Ehrlich, MD, who performed the first implant at the Kerckhoff Klinik (Bad Nauheim, Germany), said, “The Victory pacemaker comes with optimized settings right out of the box, which greatly reduces device set-up time at implant. A cardiac surgery team directed by Wolf-Peter Kloevekorn, MD, and the cardiology department, under the direction of Christian Hamm, MD, assisted in the first implant procedure. “The ability of the Victory pacemaker to measure thresholds and intrinsic events and display those results with EGMs (intracardiac electrograms) for quick verification means that 80% of standard follow-up testing is complete when the patient walks in the door,” said Johannes Sperzel, MD, who performed the follow-up on the first patient to received the device.

St, Jude Medical said the VIP technology is an enhancement developed from years of clinical experience with its AutoIntrinsic Conduction Search (AICS) feature. VIP promotes more natural heart function and minimizes ventricular pacing, the company said. This is an important clinical consideration, it said, since studies such as the St. Jude Medical-sponsored DAVID (for Dual-Chamber And VVI Implantable Defibrillator) trial have shown that excessive ventricular pacing may contribute to heart failure in some patients.

It added that the FastPath summary screen allows any necessary in-clinic testing to be completed more rapidly than was true previously. FastPath provides pre-set test values and offers flexibility with multiple follow-up options, which the company said allows clinicians to spend more time with the patient and less time programming the device. The Victory pacemakers, which presently include models 5810 and 5816, also offer a suite of algorithms designed to make it easier for physicians to manage patients with atrial fibrillation, the most common cardiac arrhythmia.

Other technology in the Victory pacemakers includes ventricular AutoCapture pacing, Advanced Hysteresis and Auto Rest Rate, which St. Jude said may improve the longevity of the pacemaker as well as reduce the number of replacement surgeries patients must undergo in the future.

Dade launches homocysteine assay for BN systems

Dade Behring (Deerfield, Illinois), a leader in cardiac diagnostic testing, last week reported launching the homocysteine assay in Europe for use on its BN II and BN ProSpec diagnostic systems. Homocysteine is a cardiac marker used to determine if a person is at high risk of a heart attack or stroke. When increased, it is found to be associated with the progression of vascular disease. The company said studies have shown that up to 47% of patients with symptoms of cardiovascular disease show elevated levels of the amino acid. Dade Behring said the addition of the homocysteine assay allows the company to provide physicians with one of the most complete cardiovascular risk assessment menus, allowing them to better diagnose a patient at risk of a heart attack. “Because heart attacks are the leading cause of death in both men and women, providing physicians with a better way to assess the health of their at-risk patients is a major priority for us,” said Jim Reid-Anderson, chairman, president and CEO of Dade Behring.

The homocysteine test may be run in a panel in conjunction with Dade Behring’s CardioPhase hsCRP, cholesterol, lipids, Apo A1/Apo B, Lp(a) and microalbuminuria tests. The company said this risk-assessment panel is run in both regular and specialized diagnostic labs. Dade Behring co-developed the homocysteine test kit through an agreement with Axis-Shield (Dundee, Scotland), a maker of in vitro diagnostic kits in cardiovascular, rheumatoid, infectious and alcohol-related diseases, together with diabetes. Axis-Shield has a special focus on near-patient testing. Dade Behring will sell and distribute the product under the Dade Behring name.

Dade Behring also reported that it has opened a new European distribution center in Duisburg, Germany. The company said the new center utilizes the latest technology and an advanced robotic system, enabling faster turnaround time for fulfillment of customer orders and the capacity for expansion and future growth. “This new center allows our people to provide customers with faster fulfillment of orders and a more efficient, streamlined distribution system,” said Reid-Anderson.

Dade Behring said it would store and distribute products for both U.S. and European customers in the new facility, which is located at logport, a logistic service center managed by the duisport-Group.

Medicsight to begin CAD studies in China

Medicsight plc (London), a developer of computer-aided detection (CAD) software, said it will begin a clinical studies program in China to evaluate and provide feedback to further enhance the company’s Medicsight LungCAD and Medicsight ColonCAD products for the Chinese market. Medicsight ColonCAD is an image-analysis software tool designed to be used with computed tomography (CT) colonography (virtual colonoscopy) to assist radiologists in searching for potential colorectal polyps. Medicsight LungCAD is an image-analysis software tool that assists radiologists in detecting and evaluating lesions or nodules found during CT scans of the lung.

A Chinese investigator team, involving several of China’s top lung and colon experts in the radiology and oncology fields, will lead the program, which Medicsight said will provide research to help further improve its CAD algorithms. The team’s experts will collaborate with Medicsight’s in-house clinical team based in London, and two leading UK radiologists, Drs. Mary Roddie and Stuart Taylor. Roddie and Taylor said, “The studies will allow us to not only further improve the software to be most effective with the Chinese population but also help us determine what clinical requirements Medicsight should consider when localizing the software for the Chinese medical community.”

“Multi-slice CT is currently widely used in China’s hospitals, but the traditional way to read the image for further diagnosis after the CT screening has certain limitations,” said Professor Ma Daqing. “Extensive research has proven that CAD software has the ability to precisely detect and accurately measure for lung cancer.” Ma Daqing is chief radiologist at Beijing Friendship Hospital and head of chest radiology for the Chinese Radiology Society.

CE mark for Pearl TMR systems

Cardiogenesis (Foothill Ranch, California), a developer of surgical products and accessories used in angina-relieving procedures, said it has received CE-mark approval for the commercial sale of its Pearl Minimally Invasive TMR (transmyocardial revascularization) delivery systems in the European Union. The Pearl Robotic 5.0 and Thoracoscopic 8.0 delivery systems are designed to reduce morbidity and recovery time for patients, while providing the same improved long term survival and enduring angina benefit achieved with the standard Cardiogenesis Ho:YAG surgical system used for TMR.

Michael Quinn, chairman and CEO, said, “Physicians will now be able to offer the impressive clinical benefits of TMR to patients, with reduced surgical incisions and a more rapid recovery. We believe that this minimally invasive surgical platform offers the opportunity to re-launch sole-therapy surgical TMR in Europe with the leaders in advanced cardiothoracic techniques.” He said the company’s advanced surgical and percutaneous devices and techniques, “have been proven to decrease morbidity rates compared to the traditional open surgical techniques.”

Quinn said, “We now have representation covering the majority of the European Union, with more to be added this quarter.”