A Medical Device Daily
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 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 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 of Conor, said that the CE mark approval for UniStar lays the foundation for European regulatory approval of its 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 Febreuary filed a CE mark application for its 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.
The CoStar stent is not yet FDA-cleared.
Mitchell to head MILLiMED
MILLiMED (Helsingborg, Sweden), a manufacturer of neurovascular and cardiovascular devices, said it has appointed Robert Mitchell as president and CEO. Mitchell joins MILLiMED from Align Technology, the inventor of the Invisalign method of straightening teeth, where he served as Vice President, Worldwide Sales and was a member of the Executive Management Committee. During his tenure, Align Technology realized a 17% increase in the number of doctors using Invisalign worldwide.
MILLiMED bills itself as “a pioneer in the growing area of nanotechnology” and as on “the cutting edge of using nano-spinning to deliver nitric oxide and other natural therapeutics to promote healing in the vasculature. “
The company recently acquired Blue Medical Devices, a developer of diamond-coated coronary stents and world-class PTCA catheter systems, providing MILLiMED a platform of cardiovascular devices and supporting its R&D programs.