Micell gains new manufacturing partner

Micell Technologies said today that it won approval to partner with contract manufacturer Surgical Technologies, Inc. in Britain and will begin full-scale manufacturing of its MiStent SES for distribution to European Union countries. Micell won CE Mark approval in the European Union for the drug-eluting stent in 2013. STI will serve as the primary contract manufacturer of the MiStent SES, according to the companies. “With STI’s expertise and performance in full-service medical device contracting and Micell’s highly efficient manufacturing process, we are accommodating the controlled commercial launch of MiStent SES in CE Mark countries as well as supplying clinical trials currently being conducted in Europe and China. We also are prepared to support a commercial launch in China once granted regulatory approval,” Micell CEO Arthur Benvenuto said in prepared remarks. Durham, N.C.-based Micell said they are currently seeking regulatory approval in China, Hong Kong and Macau, but did not mention any plans to seek approval in the U.S. “We are excited to join the team that is bringing this new class of medical device to people suffering with coronary artery disease. As a pioneer in medical contracting, STI is well suited to partner with Micell to execute commercial-volume manufacturing. Micell’s uniquely efficient manufacturing process enables scalable, high-yield throughput within a small footprint,” STI CEO Timothy Scanlan said i...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Cardiovascular Contract Manufacturing Drug-Eluting Stents Micell Technologies Inc. Source Type: news