A Medical Device Daily

EDAP TMS (Lyon, France) said a recent publication outlined successful results achieved in an Italian study of 30 men with high-risk prostate cancer who elected to pursue the company's Ablatherm HIFU therapy in conjunction with LHRH hormone therapy.

Ablatherm HIFU is used on a routine basis addressing patients with T1 or T2 localized prostate cancer who are not candidates for surgery or who wish to avoid side effects directly linked to a prostatectomy procedure.

EDAP said Ablatherm also offers an alternative to patients who failed a radiotherapy treatment where no other solution was available up to now.

It said some clinicians are expressing interest in using HIFU technology to address patients with high-risk prostate cancer (T2b-T3), thus far treated with radiotherapy sometimes associated with hormonotherapy or using surgery.

Professor Vincenzo Ficarra of the urology department at the University of Padova in Italy, working with Professor Walter Artibani, co-author of the article, said, "In our experimental study, we evaluated the potential application of HIFU and concomitant androgen ablation in a different category of patients with high-risk prostate cancer. The aim of the study was to verify if HIFU treatment could be considered a minimally invasive alternative to the current recommended treatments for these patients.

Ficarra added: "Prostate biopsies performed 12 months after the treatment showed 77% negative biopsies and 90% of the patients treated with HIFU and three monthly depot LHRH analogue preparations had undetectable PSA levels, and none had clinical progression of disease."

He said the results of the study also demonstrated that, "as in patients with low-risk localized prostate cancer, HIFU was a safe treatment for this high-risk population, with low complications. A complete urinary continence recovery was obtained in 93% of the cases after 12 months."

Ficarra added that the low complication rates, "with favorable functional outcomes and particularly the promising preliminary oncological data, support the scheduling of further larger studies in such patients."

EDAP Chief Operating Officer Marc Oczachowski said, "Dr. Ficarra's study is aiming at enlarging indications for using HIFU in prostate cancer and offering a new therapeutic alternative to high-risk cancer patients. This potentiality is interesting as it validates the successful outcomes already achieved by some Ablatherm users in addressing high-risk patients."

The study was published in December in BJU International

120 European docs discuss EGS tech

EndoGastric Solutions (EGS; Redmond, Washington), a leading firm in the field of endoluminal intragastric surgery, said that some 120 surgeons and gastroenterologists from more than 50 hospitals across Europe came together in Vienna recently to discuss the evolution of incisionless transoral digestive surgery for the treatment of gastroesophageal reflux disease (GERD) and obesity.

During the two-day meeting, users of the company's EsophyX technology presented their findings, examined their field experiences and asked questions of their colleagues in a collaborative environment EGS said was intended to help guide the development and evolution of its technology and procedures.

"The Phase I data surpassed the key endpoints for efficacy and safety that we established when we began clinical trials over 20 months ago and has demonstrated that the procedure is robust and stable," said Guy-Bernard Cadiere, MD, professor of surgery at the University of Brussels (Brussels, Belgium), the primary investigator for the Phase I clinical study. "With more than 50 centers throughout Europe beginning to adopt the EsophyX ELF approach, this was the perfect time to come together to discuss refinements and improvements to the device and procedure."

Cadiere added, "Despite the fact that endoluminal surgery is only in its infancy, the fact that these procedures mimic many of the same principles of Nissen fundoplication, and have been shown to produce similar results, makes me very optimistic about this technology."

"The results are quite impressive," said Michel Buset, MD, chief gastroenterologist at St. Pierre University (also Brussels), who presented Phase II Multicenter Study data publicly for the first time. "Over 95% of Phase II patients are experiencing a significant increase in quality of life and they love the incisionless approach. Because the procedure is non-invasive, they are able to get back to their daily activities almost immediately."

In addition to the EsophyX ELF data, EGS's second product, StomaphyX, was introduced with a presentation of recent obesity case experiences of surgeon Jacques Himpens, MD, and gastroenterologist Michel Cremer, MD.

"It is exciting partnering with a company that has developed a family of endoluminal products for the treatment of GERD and obesity," said Maastricht University Hospital (Maastricht, the Netherlands) surgeon Nicole Bouvy, MD, who has performed close to 40 ELF procedures under the company's Registry for EsophyX Fundoplications for the Elimination of Reflux.

"The early customer feedback is crucial for us to incrementally scale our business and create safe, reliable products that are effective," said Thierry Thaure, president and CEO of EndoGastric Solutions. "Our customers will best guide the development of our endoluminal procedures and we are committed to continuing to invest in users meetings and focus groups in the initial years of our rollout to fine tune the development of the EsophyX ELF, StomaphyX and other transoral endoluminal procedures."

The StomaphyX and EsophyX devices are CE-marked and available in the European Union, but are not yet available for sale or use in the U.S.

Elekta makes sale to Austrian hospital

Elekta (Stockholm, Sweden), a leader in advanced radiation treatment of cancer and brain disorders, reported receiving an order from Austrian hospital Landeskrankenhaus Feldkirch for two Elekta Synergy advanced treatment systems for intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT).

The order also includes Mosaic, an oncology information management software suit from Impac Medical Systems, an Elekta company.

The total contract is valued at more than 18 million and includes a service contract spanning over the equipment's expected lifetime.

The radiation oncology department at the 660-bed hospital offers radiation therapy for about 1,000 patients annually. Installation of the new Elekta equipment will begin near the end of 2007.

Landeskrankenhaus Feldkirch is the main regional healthcare center for the Austrian Federal State of Vorarlberg. It serves an area of about 400,000 inhabitants in the westernmost state of Austria, bordering Liechtenstein, Switzerland and Germany.