A Medical Device Daily
Cardiac Dimensions (Kirkland, Washington) reported the first implant of its Carillon Mitral Contour System as part of the new TITAN study. The procedure was performed by Michael Haude, MD, chief of cardiology at the Stadtische Kliniken Neuss (Neuss, Germany).
TITAN is the latest clinical effort initiated by Cardiac Dimensions. The study, which will be conducted in six centers across Europe and enroll up to 50 patients, will assess safety and efficacy at one, six, 12, 18 and 24 months, then annually at three, four and five years.
The Carillon system is a percutaneous treatment of functional mitral regurgitation (FMR), currently under investigational use in Europe, South America and Australia.
"The procedure went very smoothly and we were quite satisfied with the result," Haude said. "The patient had been in the hospital for several weeks prior to the procedure and is now doing very well."
Haude previously participated in the company's AMADEUS study. "In my experience with the device, the Carillon holds a great deal of promise for patients with functional mitral regurgitation," he said. "It has provided clinical benefit to those patients in whom I have placed it, and I see a tremendous opportunity for many more patients."
Rick Stewart, president/CEO of Cardiac Dimensions, said, "We are ... excited about getting the TITAN trial started. The Carillon system has met all our expectations to date, and we are pleased to kick off the TITAN trial in such a strong manner."
Roughly 5 million people in the U.S. and more than 20 million people worldwide suffer from heart failure. Cardiac Dimensions said the majority of those patients also suffer from dilated cardiomyopathy and FMR and are "inadequately treated using medical management."
It added that while surgical options exist and can be effective in reducing FMR,"they are infrequently used due to the burden of the surgery itself, which can be associated with high operative morbidity and mortality rates."
The Carillon system combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors, which is delivered percutaneously via jugular access under fluoroscopic guidance.
The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation.
The company said pre-clinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements, among other key parameters including NYHA class, six-minute walk times, and quality of life.
UK government cancels Fujitsu contract
The UK government has cancelled a huge contract with Fujitsu (Tokyo) that was part of its ambitious program to computerize healthcare records in England. The 10-year, 896 million ($1.8 billion) agreement originally was signed in January 2004 and had been set to run to 2013.
But a spokeswoman for the National Health Service's (NHS) Connecting for Health agency said Thursday that a termination notice had been issued. "Regrettably and despite best efforts by all parties, it has not been possible to reach an agreement on the core Fujitsu contract that is acceptable to all parties," she told the AFP news service.
She said negotiations on the matter had been going on since last July. "The NHS will therefore end the contract early by issuing a termination notice. Work has started immediately on [making] the necessary arrangements."
Fujitsu was responsible for installing the new e-health system in the south of England.
The Financial Times reported Thursday that the dispute centered around the government's demands for more flexibility in the IT system being installed, which would have cost more.
Fujitsu had requested either increased compensation or the continuation of the original requirements, the newspaper said in its report. A company spokesman confirmed that the talks had broken down.
The contract was part of the government's overall 12.4 billion program to computerize England's health records, one of the most ambitious such programs in the world.
ArthroCare buys its Scandinavian distributor
Minimally invasive surgical products manufacturer ArthroCare (Austin, Texas) said it has acquired OrtoConcept Scandinavia (Aarhus, Denmark), a medical device distributor specializing in the distribution of sports medicine and spine devices to surgeons throughout Denmark, Norway and Sweden.
OrtoConcept began distribution of ArthroCare's products in Denmark in 2002 and since then has expanded its operations to include the Norwegian and Swedish markets.
"The acquisition of OrtoConcept supports [our] strategic objective of direct representation in key markets outside the U.S.," said Sten Dahlborg, senior VP and general manager of international operations for ArthroCare. "It further accelerates long-term revenue growth potential, controls in-market focus and brand awareness while enhancing the operating income of the company's international business."
He cited OrtoConcept's "extremely strong customer relations within the orthopedic community, experienced personnel and an exceptionally customer-oriented approach to sales," adding that the establishment of direct sales representation in Scandinavia "will further bolster our important relationships with Scandinavian surgeons."
Dahlborg said OrtoConcept's employees already are familiar with his company's products and processes, "so the integration of the business should be relatively seamless and we are proud to have them on board our team."
Many of ArthroCare's products are based on its Coblation technology, which uses low-temperature radio frequency energy to dissolve rather than burn soft tissue minimizing damage to healthy tissue. Used in more than 4 million surgeries worldwide, Coblation-based devices have been developed for sports medicine; spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and gynecologic procedures.
ArthroCare also has added a number of other technologies to its portfolio, including Opus Medical sports medicine, Parallax spine and Applied Therapeutics ENT products, to complement Coblation within key indications.