A Medical Device Daily

CoreValve (Irvine, California) reported the initiation last week of an Australia/New Zealand-focused clinical evaluation of its percutaneous ReValving System, which features a porcine pericardium valve mounted in a self-expanding frame.

The first four procedures using the ReValving System were performed by John Ormiston, MD, medical director at Mercy Hospital (Auckland, New Zealand).

"With the ReValving system, a new heart valve can be implanted from a small hole made in the groin, and therefore there is no need for major surgery or an incision in the chest," Ormiston said. "Patient recovery is much quicker, and the procedure can be performed on patients who are at very high risk, or not candidates, for traditional heart valve surgery."

Saying the procedure is "truly a revolution in cardiology and is part of the trend toward less-invasive treatment," he noted that percutaneous aortic valve replacement (PAVR) currently is used for "carefully selected high-risk patients only ... but if good long-term results are sustained, PAVR may substitute for traditional aortic valve replacement surgery in more patients."

Daniel Lemaitre, CoreValve president/CEO, said, "We are gratified by the continued clinical acceptance of our ReValving technology, the smallest percutaneous system currently available. The extensive clinical experience we have in Europe, where we are the market leader, will greatly facilitate the introduction of our revolutionary technology in the Pacific Rim and other regions throughout the world."

He noted that several scientific presentations regarding the ReValving technology and clinical data are being presented at this week's European Society of Cardiology meeting in Munich, Germany.

The ReValving System is intended to provide an alternative to open-heart surgery. Procedures are performed on a beating heart without cardiac assistance or rapid pacing, The catheter-based technology includes a proprietary framed/self-expanding tissue heart valve designed and engineered for transcatheter delivery.

Two distributors named by Fluidigm

Fluidigm (South San Francisco, California), the developer of Integrated Fluidic Circuits (IFCs), has named distributors for its BioMark System for genetic analysis in Australia/New Zealand and Hong Kong.

Millennium Science Pty. Ltd. (Surrey Hills, Australia) will be the exclusive distributor for the system in Australia and New Zealand, and Bio-Gene Technology (Hong Kong) will be the distributor in Hong Kong.

The company said the BioMark System "has significant advantages for real-time PCR, genotyping, gene expression, copy number variation and absolute quantification for sequencing." The BioMark System uses integrated fluidic circuits that contain a microscopic matrix of channels, valves and chambers on a silicone based chip that can perform more than 2,000 experiments at a time.

"[We are] committed to bringing the accuracy and efficiency benefits of integrated fluidic circuit technology to life science researchers in Australia, New Zealand and Hong Kong," said Hazelle Lam, regional sales director at Fluidigm.

She said the partnership with Millennium Science "brings our technology and products along with Millennium Science's focus on providing next-generation research tools to scientists of this region," and added that "Bio-Gene has built a reputation over the past 15 years of addressing the needs of life sciences researchers in [that] region."

"We are ... pleased to be partnering with Fluidigm to bring their IFC technology to the life science research market throughout Australia and New Zealand. Through [its] high-throughput microfluidics products, Fluidigm significantly adds to our genomics portfolio," said Bren Collinson, founder/CEO of Millennium Science.

Desmond Hau, director of marketing for Bio-Gene Technology, said, "We believe Fluidigm's integrated circuit for biology brings new capabilities to Hong Kong's life science researchers."

Asian software launch by Camstar

Camstar (Charlotte, North Carolina) a provider of enterprise manufacturing and quality execution solutions, said it is launching its Medical Device Suite which it said already is deployed widely at device companies in the U.S. and Europe in Singapore and China.

The company noted that regulatory bodies, "in particular in the U.S. and Europe, are increasing oversight of import safety and supplier quality. As regional medical device manufacturers and electronics and component assembly suppliers prepare for rapid growth, they are under pressure to effectively demonstrate that their quality systems and processes are compliant with all required regulations and mandates."

Camstar said its software platform "facilitates compliance in global manufacturing companies by providing an enterprise-level, self-auditing, electronic manufacturing and quality audit trail that enforces the manufacturers' processes and best practices, and clearly demonstrates compliance for customers and regulatory bodies."

According to the company, Medical Device Suite "also helps manufacturers reduce costly errors, scrap and rework, and eliminates redundant paperwork checks. The audit trail, the basis of the electronic Device History Record, is accessible globally for traceability and effective root-cause analysis."

Camstar Systems' Asia competency centers are located in Shanghai, China, and Singapore.