A Medical Device Daily

Stereotaxis (St. Louis) reported that its Celsius RMT ThermoCool catheter has received the CE mark for distribution in the European market. The product is the fifth advanced ablation catheter resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster (Diamond Bar, California) to design and distribute magnetically enabled catheters for use in the Niobe Magnetic Navigation System (MNS).

A pre-market approval (PMA) application supplement for the Celsius RMT ThermoCool catheter was submitted to the FDA in September.

The Celsius RMT and NaviStar RMT families of catheters are the only magnetic catheters accurately matched to the navigational software of the Niobe MNS for optimal performance and highly precise catheter manipulation.

This catheter fills out the family of magnetic irrigated catheters to offer both localized and non-localized technology. Localized catheters are used for more complex arrhythmias requiring 3-D electro-anatomic mapping for precise diagnosis, whereas non-localized catheters are typically used for simpler arrhythmias which can be treated using basic imaging and ECG recordings.

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced X-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.

Merge, Medrad expand EU distribution deal

Merge Healthcare (Milwaukee), a health IT company, and Medrad (Warrendale, Pennsylvania), a provider of devices and services for diagnostic imaging, reported an expansion of their European Union distribution agreement for CADstream, a dedicated CAD system for MRI. The expanded distribution agreement now allows Medrad to distribute CADstream in France, as well as the UK, Germany and Italy; some of the fastest-growing markets for CAD in the EU.

"Medrad has spearheaded the availability of this important technology in Europe," said Paul Budak, president of Merge CAD (formerly Confirma). "As breast and prostate MRI study volumes increase, physicians are searching for systems that will improve the workflow of time-intensive studies. CADstream has been a market leader in breast MRI CAD in the U.S. for some time, and Medrad is a great partner to expand its deployment in the EU."

"CADstream complements the Medrad product portfolio and customers in France are requesting the product," said Anthony Cinalli, executive director, radiology marketing, Medrad.

Varian systems acquired in Portugal

Cancer patients in northern Portugal will gain access to advanced cancer treatments with the acquisition of seven new treatments machines from Varian Medical Systems (Palo Alto, California) by the Instituto Portugues Oncologia (IPO Porto; Porto, Portugal).

The order, placed in August, includes the country's first Novalis Tx device for advanced radiosurgery and two Trilogy medical linear accelerators offering RapidArc radiotherapy capability.

The project involves complete reconstruction of an institute that first began treating cancer patients in 1974 and has offered top quality cancer care for north Portugal's 3.6 million inhabitants since. Four Clinac DHX linear accelerators, ARIA oncology information software with 64 workstations and 15 treatment planning systems also form part of the largest single radiotherapy order ever placed in Portugal. Varian has also signed an eight-year service contract with the institute.

"The efficacy of radiotherapy treatments is already very well known but the improvement in quality that will come from this project will be of enormous benefit to the quality of life of patients in the north of Portugal," said Helena Pereira, MD, IPO's radio oncology service medical director. "This new equipment will allow us to introduce new radiation delivery techniques that offer more efficient and more precise ways of treating cancer while reducing side effects."

Laranja Pontes, MD, the institute's CEO, added, "We have been working with Varian for twenty years and we are very pleased with the relationship. The acquisition of this new equipment shows our faith in this relationship and our belief that Varian's equipment and software offer our patients the best treatments."

IPO Porto is a public health institution of international renown in the treatment, research and teaching of cancer, often treating the most complex cancer cases in the north of the country. In 2008, almost 3,000 new cancer patients were treated at the institute.