Medical Device Dailys

Finally some good news in radiotherapy for French Health Minister Roselyne Bachelot.

With the first year of her administration marked by revelations of thousands of patients burned by radiotherapy (Medical Device Daily; Dec. 14, 2007), Bachelot went out of her way to lead the inauguration of an advanced image-guided radiotherapy suite installed at the Georges-Fran ois Leclerc Cancer Center (Dijon, France) recently.

In addition to standard radiation therapies, the Trilogy linear accelerator from Varian Medical Systems (Palo Alto, California) offers stereotactic radiosurgery as an alternative treatment for cancers that are either inoperable or can not be treated by chemotherapies.

Combining conventional and stereotactic therapies in a single unit with on-board imaging to plan and guide dosage, Varian positions Trilogy as a versatile and high-throughput radiotherapy system.

Radiotherapies to be offered at the Dijon clinic include intensity-modulated radiotherapy treatments (IMRT), image-guided radiotherapy (IGRT) and whole-body stereotactic radiosurgery (SRS).

Professor Philippe Maingon, head of radiation oncology at the Dijon center, said the first application for the new Trilogy unit will be prostate cancer treatments using the system's advanced cone-beam CT imaging capabilities to validate the accuracy of patient set-up positioning prior to treatment in a dose-escalation program.

Five prostate cancer patients died and another 495 were severely burned in radiotherapy administered by technicians who had tampered with the settings at Jean-Monnet Hospital in Epinal, which is within the 200-kilometer service area of the Dijon clinic.

The Dijon clinic also will participate in a national clinical research trial involving hypo-fractionated stereotactic treatment of lung tumors.

Steerable pill camera demonstrated

Pill cameras are proven diagnostic tools for the colon and points south in the body, where the capsule moves slowly through the natural digestive processes, sending images at the rate of two frames per second for several hours.

But because the capsule passes through the esophagus in less than five seconds and the 5-gram imaging device drops quickly to the bottom of the stomach, pill cameras have been impractical for reliable images of affected tissue in these regions.

The first control system for a camera pill, using a hand-held magnet the size of a bar of chocolate, has been developed through a research collaboration led by the Fraunhofer Institute for Biomedical Engineering (Sankt Ingbert, Germany) and involving Given Imaging (Yokneam, Israel), Israelite Hospital (Hamburg, Germany) and Royal Imperial College (London).

The physician holds the magnet during the examination, moving it up or down and the camera capsule follows the motion precisely, according to Dr. Frank Volke of the Fraunhofer Institute.

The prototype of the steerable camera pill passed its first practical test in the human body in early June with the researchers conducting a "self-experiment" demonstrating the camera can be held in the esophagus for almost 10 minutes, even when the patient was sitting upright.

"In the future, doctors will be able to stop the camera in the esophagus, move it up and down and turn it, and thus adjust the angle of the camera as required," said Volke. "This allows them to make a precise examination of the junction between the esophagus and the stomach and we can even scan the stomach walls."

CE mark for GTX bare-metal stent

Global Therapeutics (Broomfield, Colorado), the cardiology unit of Cook Medical (Spencer, Indiana), has received CE-mark approval for a new cobalt chromium bare-metal coronary stent that the company believes will fill a demand for non-drug-eluting coronary stents among interventional cardiologists.

The Global Therapeutics GTX Coronary Stent System is available immediately in the European Union.

"Ever since the issue of late-stage thrombosis associated with drug-eluting coronary stents (DECS) came to light, interventional cardiologists have been re-examining the valuable role bare metal stents can play in treating coronary artery disease in many patients," said Joe Horn, president of Global Therapeutics.

He added, "Not only do our bare-metal stents eliminate the concerns associated with potential delayed reactions from DES in certain coronary patients, our bare-metal cobalt chromium stent has advanced features designed to improve clinical performance of BMS in coronary arteries."

Horn said the GTX stent has been engineered to eliminate such technical challenges, as recoil, stent balloon retention and stent spring-back all of which have been associated with earlier cobalt chromium stent designs currently on the market.

Global Therapeutics also is developing a DES technology using the GTX platform and an improved application of antisense gene therapy — developed by its partner, AVI BioPharma (Corvallis, Oregon) — to inhibit the proliferation of a gene known to induce the restenosis process.

The clinical trial for that stent is expected to begin in Europe in 3Q08.

MarrowXpress System gets CE mark

ThermoGenesis (Rancho Cordova, California), a supplier of products and services to process and store adult stem cells, said its European Notified Body, TUV, has issued CE-mark certification to the company for the MarrowXpress (MXP) system.

The MXP device is used to process bone marrow in a laboratory setting.

The MXP is a derivative of the company's approved AutoXpress (AXP) Platform, which is used to volume reduce and collect stem cells from umbilical cord blood. Earlier in June, ThermoGenesis reported that it had submitted a 510(k) pre-market approval application to the FDA seeking regulatory clearance in the U.S.

"We have had very encouraging feedback from a number of European centers at which bone marrow clinical trials are either underway or planned. With this approval, we can now ramp up those discussions and initiate a formal launch for the MXP in Europe," said CEO William Osgood.