Sorin Group (Milan, Italy), Europe’s largest cardiovascular device company, has elaborated on the integration plan for its Cardiopulmonary business, part of the company’s Cardiac Surgery Business Unit. The plan, previously reported by Sorin at presentations to market analysts last November and in early March, calls for its three separate cardiopulmonary products companies – COBE Cardiovascular (Arvado, Colorado), Dideco (Mirandola, Italy) and Stockert (Munich, Germany) – to be operated as a single unit, while maintaining their present locations as “centers of excellence focused on specific missions and competencies,” Sorin said

The goal is to “further strengthen the company’s market leadership position,” the company said, by improving the manufacturing flexibility, time-to-market and cost efficiencies for its cardiopulmonary heart-lung machine, autologous blood transfusion and blood management product lines.

Franco Vallana, president of the company’s Cardiac Surgery Business Unit, said the expected annual savings from the plan will be EUR 10 million in 2009 “and will start to significantly impact our bottom line in 2007.” The integration plan calls for elimination of duplicated manufacturing activities and concentration of manufacturing at the most cost-effective locations.

As a result, Sorin’s U.S. operations in the Denver area will focus on ATS blood transfusion disposable sets assembly, as well as perfusion tubing systems (PTS) design and assembly, for North American customers, and will be the focal point for distribution of Sorin products in North America. In addition, the Arvada location will continue to grow as the headquarters of Sorin Group’s North America Region, with group sales, field marketing and shared services centered there.

The Mirandola facility will host the worldwide production of the company’s Oxygenator product platform and ATS bowls, as well as ATS disposable sets assembly and PTS design and assembly for international regions (Europe and rest of the world) customers, along with distribution of CPB/ATS disposables for the international region.

Munich will host the worldwide manufacturing of all cardiac surgery equipment, along with serving as worldwide distribution center and technical service center for such equipment.

Sorin said the implementation of the plan and transfer of production processes, which will start immediately, will be done with the goal of “preserving the highest quality and reliability standards, and ensuring full compliance with regulatory approvals received from the FDA and the European Union.” The company said the integration plan completes its overall restructuring and cost reduction program, which it said is aimed at “fully realizing all the group’s untapped value.”

Besides COBE Cardiovascular, Dideco and Stockert, the companies of the Sorin Group include Bellco, ELA Medical, Mitroflow, Soludia and Sorin Biomedica. Sorin has about 4,800 employees working at facilities in more than 80 countries.

Conor coronary stent is CE-marked

Conor Medsystems (Menlo Park, California) reported that its UniStar cobalt chromium bare-metal coronary stent has received CE mark approval for the treatment of de novo coronary artery lesions.

Conor also reported receiving ISO certification of its facility in Athlone, Ireland, for the manufacturing of its coronary stents, including the UniStar stent and the CoStar cobalt chromium paclitaxel-eluting coronary stent. Conor’s Athlone facility became operational in the first quarter.

Frank Litvack, MD, CEO and chairman, said that the CE mark approval for UniStar lays the foundation for European regulatory approval of the company’s CoStar stent, and that the ISO certification “provides assurances that the manufacture of our UniStar and CoStar stents conforms to high quality standards and European regulatory requirements.”

Conor said it does not plan to immediately commercialize the UniStar stent but may introduce it through distributors later this year in countries where bare-metal coronary stents still are widely used. Conor in February filed a CE mark application for the CoStar cobalt chromium paclitaxel-eluting stent. It said it anticipates receiving CE-marking of the CoStar stent in the second half of 2005.

Pending regulatory approval, the CoStar stent will be marketed in Europe, Latin America and parts of Asia by company partner Biotronik (Berlin). In March, a limited market release of the CoStar stent began in India through Conor’s South Asian partner, Interventional Technologies.

Conor said that in contrast to conventional surface-coated stents, its stents have been specifically designed for vascular drug delivery. Its CoStar cobalt chromium paclitaxel-eluting stent incorporates hundreds of small holes acting as a reservoir into which drug-polymer compositions can be loaded. The CoStar uses polymers that are absorbed by the body after the drug is released.

Jarvik Heart receives CE mark for LVAD

Jarvik Heart (New York) reported in May that it has received CE mark certification for the Jarvik 2000 FlowMaker, a small left-ventricular assist device (LVAD) used to treat severe congestive heart failure, allowing its commercialization in Europe. The company said the certification not only makes the Jarvik 2000 more widely available to patients, but available to patients at earlier stages of heart failure.

The Jarvik 2000 is a thumb-sized titanium pump designed to be implanted inside a weakened, failing heart to boost its output of blood to the body. It has been used to treat more than 100 patients worldwide over the past five years and, according to the company, has had “high rates of success both as a bridge to transplant and for lifetime use.”

The CE mark applies to the Jarvik 2000 for both indications. The company aid that means severe heart failure patients and their doctors in Europe can choose the device as an intervention before the disease takes an irreversible toll on patients’ bodies and other organ systems.

Jarvik Heart said the device would be used more often with patients who are outpatients at the time the decision is made to implant the device. “Earlier treatment is expected to benefit patients’ health, quality of life and chances of survival,” it said.

The company said the Jarvik 2000 FlowMaker has given extremely sick patients “a near-normal quality of life,” has shown low rates of infection compared to other approved LVADs, and has had no mechanical bearing failures to date.

Its external components, including a battery and pump controller, are ultra-portable, Jarvik Heart said, weighing about a kilogram. The implanted device itself weighs only 90 grams and slips inside the left ventricle, allowing the heart to continue to fill with and eject blood.

“With their natural heart intact, Jarvik 2000 patients do not feel the device at work, they retain a pulse, and they often have recovery of their own heart to some degree,” the company said. “Their quality of life approaches the ideal for this type of mechanical circulatory support device: ‘forgettable’ use by the patient.”

Jarvik Heart said the first patient to receive the Jarvik 2000 for lifetime use is active and in good health almost five years after implantation. He is the longest surviving patient in the world continuously supported by any type of mechanical heart.

The company said it would be seeking to partner with “exceptional” medical centers throughout the European Union to make the Jarvik 2000 FlowMaker available to patients who can most benefit from it.

Robert Jarvik, MD, inventor of the Jarvik 7 and Jarvik 2000 mechanical hearts, is president and CEO of Jarvik Heart. Leon Hirsch, founder and former chairman of U.S. Surgical (Norwalk, Connecticut), now a Tyco Healthcare (Mansfield, Massachusetts) company, serves as chairman of the board.

1st patient enrolled in Holly Graft trial

Enrollment has begun in CABG Medical’s (Minneapolis) clinical trial for CE mark approval of the Holly Graft System, a drug-eluting graft (DEG) for facilitating a coronary artery bypass procedure. The implant of the graft system in the first patient enrolled in the clinical trial – the second patient treated with the system – was completed by Peter Tesar, MD, and Trevor Fayers, MD, at Prince Charles Hospital (Brisbane, Australia). The two surgeons also completed the first implant of the Holly Graft System last November.

The Holly Graft System is designed to treat blockages in multiple coronary arteries from a single graft. The Holly system consists of a flexible, thin-walled vascular graft made of expanded polytetrafluoroethylene; it is attached to the coronary arteries via connectors coated with a drug combination to reduce the risk of blockage and thrombosis. The major benefit of the system is to eliminate a secondary surgery conducted as part of a heart bypass procedure to harvest healthy vessels from the chest, legs or arms for use in the bypass, the company said.

Well-known med-tech entrepreneur Manny Villafana, who is chairman and CEO of the company, said, “We have worked closely with our scientific advisory board and our physician collaborators over the past four years in developing a technology that had a safety profile that was adequate to move into human evaluation.” He said the incorporation of a paclitaxel drug into the system “has made a profound difference that could positively impact the effectiveness of the device.”

Noting that the CE mark is the designation for approval in major markets outside the U.S. and Japan,” Villafana said, “We are excited to begin this important work with some of the most prominent cardiac surgery centers in the world.”

CABG Medical raised more than $30 million in an initial public offering of some 5.5 million shares late last year and subsequently added another $4.5 million through sale of an additional 825,000 in the exercise of over-allotment options.

MRI used to examine statin’s effects on plaques

Results of the first study to use magnetic resonance imaging to examine the effect of a statin, rosuvastatin – Crestor from AstraZeneca (London) – on the fatty plaques in arteries, were presented last month at the 75th European Atherosclerosis Society congress in Prague, Czech Republic. The ORION study, which is part of the GALAXY global research initiative sponsored by AstraZeneca, maker of Crestor, to investigate cardiovascular risk reduction and patient outcomes with rosuvastatin, revealed that rosuvastatin has a beneficial effect on the size and composition of fatty plaques in arteries, specifically the carotid artery in the neck.

Results from the ORION study indicate substantial reductions in LDL cholesterol (the so-called “bad” cholesterol) with rosuvastatin treatment were associated with arrested progression of atherosclerosis and regression of the large fatty core (lipid-rich core) in the most diseased sites of plaques. Plaques with a lipid-rich core are recognized to be vulnerable to rupture, which can result in sudden cardiovascular events such as heart attacks and strokes, often without any prior symptom.

T.S. Hatsukami, MD, of the University of Washington School of Medicine (Seattle), lead investigator of the ORION study, said, “Results from ORION, a study that uses advanced MRI techniques to characterize plaque size and composition, suggest that intensive LDL-C lowering treatment with rosuvastatin may reduce the lipid-rich areas at the most diseased sites within carotid plaques, and is associated with arrested progression in overall plaque burden.”

Gish Biomedical gets Japanese clearance

CardioTech International (Wilmington, Massachusetts) said that its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received clearance to sell its Stat-Sat oxygen saturation monitor in Japan.

The Stat-Sat device measures venous and arterial oxygen saturation, hematocrit and hemoglobin in-line as part of cardiopulmonary bypass procedures. Its disposable arterial filter separates air from blood and filters particles from the circuit during bypass surgery.

About 48,000 cardiac surgery procedures are conducted annually in Japan, representing an important export market for Gish.

Douglas Whittaker, president of Gish, said the company’s Japanese distributor, Heiwa Bussan, received regulatory clearance from the Ministry of Health and Welfare to sell Stat-Sat Oxy-Sat Monitor and Arterial Filter products in that country.