A Medical Device Daily

Biotronik (Berlin) a pioneer of wireless remote monitoring technologies and a manufacturer of implantable cardiac devices, reported that it has received the CE mark for its remote patient monitoring technology. Biotronik Home Monitoring is now approved to safely replace in-hospital device follow-up visits. This new CE mark follows the recently received equivalent FDA approval granted in May, 2009.

Biotronik Home Monitoring is a fully wireless, mobile remote monitoring system for patients with implantable cardiac device. The European approval is based on the landmark TRUST Trial which the company said proved that the system can safely and effectively replace conventional in-hospital device follow-up visits. Patients can be remotely monitored securely through the wireless system with only one annual in-clinic visit. In addition, the TRUST trial also demonstrated that the system, with its automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic events and device system anomalies allowing for earlier physician intervention than conventional in-hospital follow-ups.

Exiqon launches MicroRNA qPCR platform

Exiqon (Copenhagen, Denmark) reported the global launch of its new platform for quantitative real-time PCR analysis of microRNAs. The new miRCURY LNA Universal RT microRNA PCR product line combines all the advantages of LNA technology with a Universal reverse transcription (RT) step, resulting in the most sensitive microRNA expression profiling system currently available, the company said.

The use of two LNA-enhanced PCR primers results in both exceptional sensitivity and specificity, enabling accurate quantitation of very low microRNA levels, and discrimination between closely related microRNA sequences. According to the company, the universal RT step greatly reduces sample input requirements and technical variation, and most importantly saves time in the laboratory.

The new microRNA qPCR product line includes Ready-to-Use qPCR panels, combining performance and ease of use for exceptionally sensitive expression profiling of 730 human microRNAs. The new panels have already been shown to enable accurate and reproducible expression profiling from samples with limited RNA yields such as FFPE sections and serum/plasma samples.

"This is truly an enabling product," says Cynthia French, CSO for Exiqon. "This new microRNA qPCR platform will make expression profiling of microRNAs possible from even smaller amounts of high value, clinically significant samples than previously thought possible." In addition to the microRNA Ready-to-Use qPCR panels, all 730 primer sets are also available as individual microRNA assays. The platform also offers assays for reference genes and three new reagent kits for quantitative real-time PCR of microRNA species.

Grifols to open new national testing laboratory

Grifols (Barcelona, Spain), a global healthcare company, reported that it broke ground on a new national testing laboratory in San Marcos, Texas. Construction of the laboratory represents the first phase of a multi-phase expansion that includes additional warehousing and production facilities. When completed, the new facilities will represent a $76 million capital investment and will complement Grifols' existing facilities in Los Angeles and Barcelona, Spain.

The plasma medicines Grifols produces are used to treat a variety of rare, chronic and often life-threatening diseases such as PIDD, hemophilia and other bleeding disorders, as well as shock, trauma and burns.

"We are pleased to make San Marcos home to our new facilities," said Gregory Rich, President of Grifols U.S. operations. "Business incentives offered by the city, county and state have helped us realize the goal of preparing for future patient needs of the critically important plasma medicines that we produce."

Texas is investing $500,000 in the Grifols expansion project through the Texas Enterprise Fund. The city and county provided substantial incentives to Grifols in the form of property tax relief.

Texas has been an important business hub for Grifols for many years. Currently the state is home to 17 Grifols donor centers and the company's current testing laboratory in Austin. Grifols employs more than 600 Texans and contributes more than $80 million annually to the Texas economy through payroll and other business expenses. Plasma and intermediate products are often shipped to the company's Barcelona facilities through the port of Houston. Construction of the new laboratory, warehousing and production facilities in San Marcos will secure Texas as an essential long-term business home for the company.

curasan receives license for ATR

curasan (Kleinostheim, Germany) reported that it has received the CE mark for its ATR (Advanced Tissue Regeneration) product.

ATR is a disposable system that is used to enrich the body's own growth factors to a level many times higher than normal blood values. The most important areas of application are serious skin damage, such as decubitus and ulcers, large area burns, skin transplants, plastic surgery and the optimized regeneration of bone and mucous tissue.

According to the company, a crucial advantage of the product is that it is a disposable system. This means that, in contrast to PRP (platelet rich plasma); it can be used without the aid of centrifuges and thereby saves the user expensive capital goods. Furthermore, a much higher concentration of growth factors that are free from superfluous accompanying substances is achieved.

The issuing of the certification means that preparations for full scale production can begin and ATR is now scheduled to be ready for distribution in early 2010.

"We now have the perfect basis from which to conduct successful negotiations for the awarding of distribution licenses," said Hans Dieter Rössler, CEO of curasan. "Our aim is to co-operate with various distribution partners that can already demonstrate optimal positioning in their particular markets and segments."