A Medical Device Daily

Boston Scientific (Natick, Massachusetts) said it has received CE mark approval for its Taxus Element Paclitaxel-eluting coronary stent system, the company's third-generation drug-eluting stent technology. This approval includes a specific indication for the treatment of diabetic patients. The Taxus Element stent system incorporates a platinum chromium alloy with an “innovative stent design“ and an advanced catheter delivery system, according to Boston Scientific. The company plans to launch the Taxus Element stent system next month in the European Union and other CE mark countries.

The Taxus Element stent is designed specifically for coronary stenting and leverages the performance advantages of the Element platform with a decade of clinical success from the Taxus program. According to the company, the stent architecture and platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system, the company noted. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents.

The company received CE mark approval for the Promus Element Everolimus-eluting stent system in October 2009. Both Element systems incorporate the same platinum chromium alloy, stent design and advanced catheter delivery system.

In March, the company reported 12-month results from its PERSEUS clinical program demonstrating positive safety and efficacy outcomes in workhorse lesions for the Taxus Element stent system compared to the Taxus Express2 stent system. The results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the Taxus Element stent compared to a historical control group of patients receiving the Express bare-metal stent.

In the U.S., the company expects FDA approval for the Taxus Element in mid-2011 and for the Promus Element in mid-2012. In Japan, the company expects approval for the Taxus Element in late 2011 or early 2012 and for the Promus Element in mid-2012.

Biosense Webster completes Thermocool cases

Biosense Webster (Diamond Bar, California) reported the completion of the first clinical cases with the new Thermocool SF irrigated ablation catheter in the European Union, following recent CE mark approval. The Thermocool SF catheter is the most advanced Biosense irrigated ablation catheter for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms.

The Thermocool SF irrigated catheter is the next generation in irrigated ablation catheters and builds upon the Thermocool irrigated catheter platform. According to Biosense, the Thermocool SF catheter's “unique design“ and porous tip technology provides EPs with uniform cooling across the entire catheter tip and allows efficient cooling at half the flow rate.

Biocius opens European office

Biocius Life Sciences (Woburn, Massachusetts), developer of the label-free RapidFire high-throughput mass spectrometry platform, said it has expanded its operations, opening a European office and naming Gregory Werner as EU sales manager.

Located near Geneva, Switzerland, the new Biocius subsidiary will provide expert sales and service support to the company's growing European customer base. RapidFire technology enables pharmaceutical and biotechnology companies to accelerate their drug discovery research with high-throughput screening solutions for lead discovery and in vitro ADME applications.

Biocius also extended its value-added reseller agreements with ABSciex (Foster City, California) and Agilent Technologies (Santa Clara, California) to include Europe, enabling Biocius to offer an end-to-end high-throughput solution for drug discovery and analysis. “Expansion of our strategic relationships with mass spec market leaders ABSciex and Agilent allows us to provide our customers with a complete system – including a RapidFire integrated with either a triple-quadrupole or time-of-flight mass spectrometer,“ said Jeffrey Leathe, chairman/CEO of Biocius. “Further strengthening these key collaborations combined with the addition of dedicated resources will enable us to build on RapidFire's success in Europe and continue the growth trajectory Biocius is currently experiencing.“

Derma Sciences establishes subsidiary

Derma Sciences (Princeton, New Jersey), a device and pharmaceutical company focused on advanced wound care, says it has established an international subsidiary, Derma Sciences Europe, and will soon be opening an office near London.

“Europe represents a substantial growth opportunity for Derma Sciences and is a logical next step in expanding our sales efforts,“ said Edward Quilty, Derma's chairman/CEO. “Europe currently dominates the global advanced wound care market, representing more than 40% in annual advanced wound care sales volumes. In addition, Europe leads all other regions in the utilization of moist wound care dressings, a category in which we excel.“

Derma Sciences also said it has hired Maeve Kelly as managing director of its Europe, Middle East, and Africa regions.