A Medical Device Daily

Endogun Medical Systems (Kiryat Shmona, Israel), a developer of solutions for minimally invasive fastening of soft tissue, reported receiving CE-mark approval for its single-incision, trans-vaginal EndoFast Reliant device for repair of pelvic organ prolapse and stress urinary incontinence (SUI).

CEO Elad Naggar said, "The CE mark is a key milestone toward bringing Endogun's prolapse and SUI product to market. We believe that our solution may have significant advantages over what is available today, for patients, physicians, payers and providers."

He said the EndoFast Reliant device makes possible "a simple procedure [that] may improve safety and reduce the overall costs associated with prolapse and SUI repair."

Pelvic organ prolapse occurs in women, often following multiple births or excess weight, and develops as a result of weakening of the pelvic muscles which support internal organs, including the womb, bladder, rectum and vagina). The company said side effects of this condition include discomfort, a feeling of heaviness, and pain and the disorder carries the risks of inflammation and infection.

About 500,000 procedures are performed annually in the U.S. and Europe combined, Endogun said, with direct costs of associated surgical equipment reaching hundreds of millions of dollars. It said estimates suggest that close to 7 million women are in need of such treatment with the gap between the potential market size and the actual number of procedures performed to date "stemming from the fact that the current surgical offerings are significantly invasive, and require substantial surgical skills."

The company said its product is aimed at offering a simpler and safer procedure for Prolapse and SUI repair, which is performed entirely intra-vaginally.

Endogun was granted FDA clearance in September 2006 to market the EndoFast Reliant for soft-tissue attachment in the U.S.

Major Swedish project awarded to Varian

Varian Medical Systems (Palo Alto, California) said its advanced treatment planning and information management software has been selected as part of a major project to integrate all radiotherapy activities in Stockholm, including those of Karolinska University Hospital (Stockholm, Sweden).

Varian's ARIA information and image management software and Eclipse treatment planning software will be installed over the next year in an effort to unify the Karolinska, South and Danderyd hospitals, which recently merged under the title of Karolinska University Hospital.

ARIA is a comprehensive cancer solution that allows medical and radiation oncologists to track adjuvant chemotherapy and radiotherapy treatments.

Hundreds of cancer patients are treated daily on 12 linear accelerators and brachytherapy afterloaders at the three sites. Most of the hospital network's treatment machines are Varian Clinac accelerators. The new Karolinska University Hospital currently deploys a variety of treatment planning, information management and verification software systems, all of which will be replaced by Varian's ARIA and Eclipse systems over the coming year.

Aris Tilikidis, chief physicist at Karolinska University Hospital, said, "An integrated system improves treatment quality by eliminating possible errors due to data transfer between different systems, resulting in more accurate treatments. Radiation therapy treatments have increased in volume and complexity in recent years and it is extremely important to be able to integrate activities effectively."

He said a single software system to manage the three networked hospitals will enable patients to be transferred seamlessly from one hospital to another. And advanced radiotherapy treatments such as IMRT (intensity-modulated radiotherapy) and IGRT (image-guided radiotherapy) benefit greatly from the use of common methods and systems across a network of hospitals.

"We analyzed all of the different companies and visited recommended reference sites and it soon became obvious to us that only the Eclipse/ARIA system from Varian could offer the integration capabilities required by our hospitals," Tilikidis said.

Sten Hornsleth, Varian's Scandinavian regional manager, said, "We are [pleased] that this major project will be served entirely by Varian's IT network. This means that Varian is the only radiotherapy IT supplier to hospitals in Stockholm, just as we are already the only supplier to other Nordic capitals [of] Helsinki and Copenhagen."

Two more sites join in CardioFit trial

BioControl Medical (Yehud, Israel) reported that cardiologists and surgeons at University Hospital Mannheim in Germany and Ospedali Riuniti di Bergamo in Italy have successfully implanted the company's CardioFit device in the first patients to be enrolled at those sites in BioControl's international, multi-center clinical study of the CardioFit system for the treatment of advanced congestive heart failure.

The CardioFit system works by applying electrical impulses to the vagus nerve. A sensing electrode in the right ventricle detects the patient's heart rate and is used to control nerve stimulation.

"Our early results support our belief that CardioFit may contribute significantly to how heart failure patients are treated in the future," said M. Borggrefe, MD, principal investigator for the BioControl trial at Mannheim.

A. Gavazzi, principal investigator for the BioControl study at Bergamo, said, "Clearly, there is an unmet clinical need for effective treatments for this condition. We believe the CardioFit system has a high potential to fill this need."

The study is now in progress at IRB-approved sites in Europe, Israel and Australia. Bergamo and Mannheim join four other sites in Europe actively enrolling patients for the CardioFit system study, all of which have already successfully implanted the device in trial patients. A total of 30 patients will be enrolled in the study.

BioControl develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes.

In April 2006, American Medical Systems (Minnetonka, Minnesota) exclusively licensed BioControl's technology for its miniaturo system, to develop it as a treatment device for urge incontinence and interstitial cystitis. Funds secured from that transaction are being used by BioControl to support the development of the CardioFit system for the treatment of CHF.