A Medical Device Daily

Boston Scientific (Natick, Massachusetts) that it has received 510(k) clearance from the FDA and CE mark approval to market its WallFlex fully covered esophageal stent for the treatment of malignant esophageal strictures caused by tumors in patients with resectable or non-resectable esophageal cancer.

The WallFlex stent was cleared by the FDA and received the CE mark in 2008. Both stents — along with the complete WallFlex sent family of self-expanding metal stents (SEMS) — will be available for hands-on demonstration at the GASTRO 2009 conference, which is being held Nov. 21-25 in London.

"The low profile delivery system (18.5 Fr) of the WallFlex esophageal stents has allowed me to traverse tight strictures, facilitating stent placement within malignancies that, in the past, needed to be pre-dilated," said Drew Schembre, MD, Chief of Gastroenterology at Virginia Mason Medical Center (Seattle). "Moreover, the fully covered option may be a viable choice for patients with operable esophageal cancer who are undergoing chemotherapy and radiation treatment in preparation for surgery."

Patients with obstructions due to esophageal cancer may have difficulty swallowing, resulting in severely limited quality of life. Complete blockages of the esophagus can prevent liquid consumption. The WallFlex stent allows physicians to re-establish patency of the esophagus, enabling resumption of oral intake.

"The availability of the complete line of WallFlex Fully and Partially Covered Esophageal Stents represents a tremendous milestone for Boston Scientific," said Michael Phalen, president, Boston Scientific Endoscopy. "This advanced line of esophageal stents is designed to improve the quality of life for the thousands of patients suffering from esophageal cancer. We are pleased that our entire WallFlex Stent family — biliary, enteral and now esophageal — is available in the U.S., Europe and other strategic international markets.

UCH introduces radiotherapy treatments

Two female brain tumor patients have become the first people in the south of England to be treated using a faster form of radiotherapy that extends more advanced care to more patients. RapidArc technology from Varian Medical Systems (Palo Alto, California) makes it possible to deliver image-guided IMRT (intensity modulated radiotherapy) two to eight times faster than is possible with conventional IMRT.

Clinicians at University College Hospital (UCH; London) carried out the pioneering treatments in October, making it only the second hospital in the country to introduce the technique routinely. Both patients were treated using a single arc - or rotation- of the machine around the patient and the treatments were delivered in under two minutes, compared with 10-15 minutes for conventional IMRT.

"RapidArc performed very satisfactorily in its first treatments, addressing what would have otherwise been difficult brain tumor volumes," said Susan Short MD, consultant clinical oncologist in charge of the brain unit at UCH. "It delivered lower overall dose to tissue outside the target area compared with IMRT, which was particularly important in the first case because the patient had received previous radiotherapy." Minimizing dose to healthy tissue reduces the possibility of complications.

"The radiotherapy department is very impressed and it is quite a straightforward treatment from the patient's point of view," she added, explaining that benign brain tumors can cause cranial nerve problems and visual problems if untreated. "We won't know yet whether it has been successful in shrinking the tumors as it can take some time to determine that, but certainly the shorter treatment time is more convenient and allows for a more comfortable treatment for our patients."

Anna Cassoni, lead clinical oncologist at University College London Hospitals NHS Foundation Trust (UCLH), said, "RapidArc produced a lower dose to the optic nerve than conventional IMRT treatment and its precision minimized exposure to surrounding critical tissues."

Faster treatments allow for greater precision, since there is less chance of patient or tumor movement during treatment delivery and, with less time on the treatment couch, also allow for greater patient comfort. Conventional IMRT treatments are slower and more difficult for radiotherapy radiographers because they target tumors using a complex sequence of fixed beams from multiple angles.

Clatterbridge Centre for Oncology became the first in England to introduce RapidArc late last year and several other English cancer centers including hospitals in Exeter, Norwich, Leicester, Stoke, Ipswich and London have installed the system and will commence treatments early in 2010.

SCS releases German language web site

Specialty Coating Systems (SCS; Indianapolis), maker of Parylene conformal coatings and technologies, reported the launch of its German language web site. Global visitors to the SCS web site are now able to access the German site by visiting the homepage at www.scscoatings.com and selecting "Deutsch" in the "Select Language" drop-down, located in the upper left corner of the page.

"We take pride in having coating locations around the world and believe it is valuable to make doing business in these regions as convenient as possible," said Tim Bender, Executive VP, Sales & Marketing. In addition to the German language site, SCS also offers a Japanese site at www.parylene.co.jp.

For more information about SCS, or our industry-leading line of conformal coating services and technologies, please visit www.scscoatings.com.