A Medical Device Daily

PPD (Wilmington, North Carolina) reported that it has officially opened its contract research facility in Athlone, Ireland, which includes an 18,000-square-foot analytical testing laboratory and clinical supplies business. The company said the facility expands the company's global scientific expertise, laboratory capacity and supplies network to meet growing client demand in Europe, Middle East and Africa for these services.

PPD will offer fully integrated product and analytical development services, including method development; validation; stability, release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage. The facility will also provide regulatory services, product licensing and marketed product support, including qualified person services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.

The cGMP analytical testing laboratory conducts testing for clinical programs and marketed products spanning all phases of drug development and builds upon more than 20 years of PPD laboratory expertise. It joins the company's scientific and therapeutic experience with state-of-the-art facilities and instrumentation to deliver comprehensive, best-in-class laboratory services.

Expanding our laboratory operations into Europe enables us to continue to deliver on our strong history of providing quality work and customer service to our growing client base in this region,“ said Magdalena Mejillano, vice president of laboratory services, PPD. “The Irish government, through IDA Ireland, has provided us strong support, and we continue to benefit from Ireland's highly skilled work force and business-friendly climate. We are pleased to join Athlone's strong, growing pharmaceutical and biopharmaceutical sectors.“

The facility represents PPD's initial investment toward continued growth of its contract research operations in Ireland, having already expanded its medical communications safety call center operations into Athlone.

PPD has already hired 21 employees in Athlone and plans to create approximately 250 jobs at the laboratory to include Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals. The company is investing up to $19 million (or €14 million) to develop the facility.

It has applied to the Irish Medicines Board (IMB) for manufacturer licenses to support both investigational medicinal products and marketed products and laboratory certifications for quality control of medicinal products. As of March 1, PPD's license applications have been assessed, and the quality system and premises inspected by the IMB. The progression of PPD's applications are under active consideration by the IMB.

PPD is a global contract research organization that provides discovery and development services. Its clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.

NovaStent gets CE mark for SAMBA stent

NovoStent (Mountain View, California) reported that it has received the CE mark for its SAMBA Stent and Delivery System for the treatment of peripheral artery disease. The SAMBA Stent was designed to treat the highly varied presentation of atherosclerotic disease in the superficial femoral (SFA) and popliteal arteries by providing a unique combination of strength, flexibility and vessel coverage.

CE mark approval was supported by data from NovoStent's SAMBA trial which enrolled patients in Germany in 2009. Partial 6-month results of the SAMBA trial were presented in January at the International Symposium on Endovascular Therapy by Michael Dake, MD, of the Stanford University (Stanford, California) School of Medicine. Lesions treated in the trial included a wide spectrum of disease such as total occlusions, eccentric calcified plaque, ulcerating lesions and thrombotic occlusions. Also included in the trial were several isolated popliteal lesions. Physicians typically avoid placing stents in the popliteal artery for fear of stent fracture.

MiMedX garners CE mark for HydroFix

The MiMedx Group (Marietta, Georgia) reported that it received the CE mark for its HydroFix Spine Shield device and was certified for design, development, and production of post-surgical adhesion inhibiting barriers. The HydroFix is indicated for use in specific locations as a cover of the spine to provide a plane of dissection during a revision surgery. The proprietary, patented, and biocompatible polyvinyl alcohol polymer (PVA) membrane may reduce the risk of injury that may be associated with anterior vertebral surgeries. By covering the spine at the surgical repair site in anterior spine surgeries, HydroFix Spine Shield creates a plane of dissection for revision surgeries.

The HydroFix is a permanent and biocompatible implant that is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures.