Medical Device Daily and MDDs

One month after receiving the CE mark for a new stent platform, two companies competing head-to-head in Europe with the technology, reported implanting their respective devices in patients in Germany and Italy.

A total of six BioMatrix stents from Biosensors International (Singapore/Newport Beach, California) were used to treat three patients at the Helios Heart Center (Siegburg, Germany) in procedures performed by Eberhard Grube, MD, chief of cardiology at Helios, and Gregg Stone, MD, director of cardiovascular research and education at New York Presbyterian Hospital-Columbia Medical Center.

The most complicated case involved a 57-year-old man presenting with a totally occluded left anterior descending artery (LAD) and a partially occluded right coronary artery (RCA), who received three stents.

Meanwhile in Milan, Italy, on Valentine's Day, Antonio Colombo, MD, director of the cardiac catheterization laboratory at Columbus Hospital and San Raffaele Hospital, implanted a Norobi stent from Terumo (Tokyo) in a case that was transmitted live to the Joint Interventional Meeting being held in Rome.

Both the BioMatrix and Norobi devices are drug-eluting stents (DES) combining a bioresorbable polymer with the limus drug, Biolimus A9, an analogue of sirolimus, which so far has shown reduced tissue proliferation compared to market-leading DES.

European regulatory approval was based on results from the BioMatrix STEALTH I trial (Stent Eluting A9 BioLimus Trial in Humans) and the results of Nobori clinical programs.

NOBORI 1 is a 360-patient, prospective 2:1 randomized trial comparing Terumo's stent with the Taxus stent from Boston Scientific (Natick, Massachusetts) in 29 centers across Europe, Asia and Australia. The NOBORI CORE trial goes up against the Cypher stent from Cordis (Miami Lakes, Florida), and at one year showed superiority on several counts.

Terumo said it is now planning an ambitious 5,000-patient randomized trial and post-marketing registry in Europe, Asia, New Zealand and Africa.

Biosensors licensed the platform to Terumo, with exclusive rights for Japan and non-exclusive rights in the rest of the world, excluding the U.S.

Terumo Europe (Leuven, Belgium) has twice trumped BioMatrix with first-to-market announcements as the competition for distribution of their new stents heats up.

France's DMS boosts revenues by 22%

Diagnostic Medical Systems (DMS; Montpellier, France), a specialist in radiology equipment and bone densitometers, reported a 22% increase in revenues for 2007 to top 131 million ($46 million), beating its objectives and predicting it will sustain this rate of growth in 2008.

More significantly the company announced a return to profitability, generating a net margin of 12.6 million ($3.8 million) against a near 11 million ($1.46 million) loss the previous year. DMS had not earned a profit since 2001.

DMS introduced new products to the market in 2007 that it expects will boost sales this year, including an ultrasound for osteoporosis test called Stratos, a digital mammography unit called Serenys, and a digital radiology detector called Da Vinci.

Chief Executive Antoine Rabaste projected that more than 30 units of the Da Vinci will be delivered in 2008.

The Da Vinci is touted as featuring a larger-scale surface than competing lines, with one-shot imaging that the company promotes for faster patient throughputs. The line includes a low-end universal system, a double-detector system, and a multi-purpose single detector designed for general radiology, traumatology and emergency departments.

DMS's revenues are nearly evenly split between bone densitometers at 44% and radiology equipment at 46%, with the balance coming from maintenance and servicing contracts.

Europe accounts for more than half of sales, followed by the Middle East at 18%, the Americas at 11.5% and Asia at 9.5%.

The company went public in 1998 and trades on the Euronext exchange in Paris, capitalized at 125 million ($36.75 million).

First 'arc therapy' treatments carried out

Royal Marsden Hospital (Sutton, UK) and Allgemeines KrankenHaus/Medical University of Vienna in Austria have successfully completed the world's first image-guided, intensity-modulated arc therapy patient treatments using commercially released product solutions.

The British hospital pioneered clinical use of an Elekta Synergy image-guided system fitted with the new Elekta (Stockholm, Sweden) linear accelerator control system in order to deliver volumetric intensity-modulated arc therapy (VMAT) to a patient undergoing a course of radiation therapy treatment for lung cancer.

"We treated our first patient with the VMAT (volumetric intensity-modulated arc therapy) technique" on Jan. 28, reported Jim Warrington, head of radiotherapy physics at Royal Marsden. "The patient received a single 340-degree arc of 6MV X-rays, with simultaneously variable gantry rotation speed, dose rate and dynamic multi-leaf collimator modulation."

Warrington called the efficiency and flexibility of the technique "impressive," and added, "We anticipate that when used in conjunction with our Elekta Synergy image-guidance systems and employing non-coplanar angles of delivery, VMAT will be a significantly improved treatment modality for [our] radiotherapy patients."

Elekta said the two main benefits of this technology "promise to be significant reduction in treatment time — in the case of the Royal Marsden treatment, 50% from the patient's previous conformal plan — combined with a significant improvement in conformance to the target and sparing of dose to adjacent healthy tissues."

An additional benefit of reducing treatment times, according to the company, is greater comfort for the patient, "which in turn ... increases the likelihood of delivering radiation beams more accurately as targeted."

During the same week, Allgemeines KrankenHaus/Medical University of Vienna delivered the world's first PreciseBEAM VMAT treatment. PreciseBEAM VMAT is delivered as a combination of optimized treatment planning using Ergo++ and an Elekta Synergy linear accelerator, upgraded with a next-generation digital control system.