Invatec: Translating Global Success in Vascular Devices to the US Market
Invatec has grown to be the leading native European interventional vascular device company and has now set its sights on the US market. By focusing first on peripherals and following with drug-eluting balloons, not stents, Invatec is looking to compete against the major device companies on their home turf.
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German serial entrepreneur Michael Orlowski achieved a successful exit in his first cardiovascular device company, EuroCor, by selling not to a US-based giant, but to an Indian conglomerate, Opto Circuits. His new company, Cardionovum, has developed a next-generation drug-eluting balloon whose novelty rests on a different approach to the coating technology designed to produce better drug-elution. With CE mark in hand, Cardionovum is preparing to launch its products in Europe. The US is a logical next target, but the high cost of clinical trials and the ever-lengthening regulatory approvals process has made the US an even more difficult market to penetrate, forcing companies like Cardionovum to contemplate strategies that bypass or put off a US launch.
Drug-coated balloons were once thought to be an unnecessary innovation because of drug-eluting stents. With DES no longer seen as the panacea for vascular disease, balloons could re-emerge as the next major technology platform, and Lutonix is leading the race to bring them to the US market.
According to "US Markets for Peripheral Vascular Stents," a report recently published by the Medtech Insight division of Elsevier Business Intelligence, the peripheral vascular stent market yielded more than $1 billion in revenues in the US in 2009, and will continue to grow at an overall rate of 7.2% in coming years, with some product segments growing even faster. Stents for carotid arteries are expected to yield a 36.5% annual compound growth rate through 2014 and endovascular products for the repair of aortic aneurysms (AAA) will grow by 8.4%, according to the Medtech Insight report. AAA endografts accounted for 43.7% of peripheral vascular stent sales last year.