A Medical Device Daily

Hologic (Bedford, Massachusetts), maker of a broad range of diagnostics, imaging systems and surgical products dedicated to women's healthcare, said it has received CE-mark approval for its Adiana permanent contraception system.

The Adiana system is designed to provide a minimally-invasive, non-incisional alternative to traditional, surgical means of female sterilization.

The procedure utilizes hysteroscopy, generally requires only local anesthesia, and can be performed in a physician's office. Patients are normally able to return to work or resume their everyday activities within a day.

Hologic said that in contrast, bilateral tubal ligation – often referred to as "getting your tubes tied" – is usually performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. Four to five days of recuperation follows.

Gynecologist Sebastiaan Veersema, MD, of St. Antonius Hospital (Nieuwegein, The Netherlands), said, "Transcervical methods of female sterilization offer significant advantages compared to traditional laparoscopic approaches. The availability of alternative, reliable sterilization devices will improve women's choice when considering methods available to them as they seek permanent contraception."

Andrew Baxter, consultant and honorary senior lecturer in the department of obstetrics and gynecology at the Royal Hallamshire Hospital (Sheffield, UK), added, "Hysteroscopic sterilization ... allows women to avoid hospital admission, anesthetics and the discomfort and risks attached to laparoscopy. We find that our patients can go home after half an hour and are back to normal within a couple of days."

Receipt of the CE mark allows Hologic to market the Adiana system in the 27 countries of the European Union and three of the four member states of the European Free Trade Association. CE marking also is recognized in many countries outside of Europe, giving Hologic the ability to supply systems to a number of other international markets.

In the U.S., the company's pre-market approval application for the Adiana system is under FDA review, and Hologic said it is in the process of registering the system in Canada and Australia.

CE mark for CardioFit

BioControl Medical (Yehud, Israel) said that its CardioFit system has received CE-mark certification from KEMA, its Dutch notified body. CardioFit was approved for marketing in Europe based on the results of a recently completed pilot study.

Intended as a treatment for NYHA class II-III heart failure patients who have failed to achieve symptomatic improvement through standard evidence-based management, CardioFit 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.

"This ... provides an important seal of quality for CardioFit and opens important markets," said CEO Dr. Ehud Cohen. "We are grateful to the physicians who worked with us in the clinical study and provided us with the opportunity to introduce this therapeutic technology to clinical practice."

BioControl develops 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. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results.

German appeals court backs AGA

AGA Medical Holdings (Plymouth, Minnesota) reported that a German appeals court has ruled in its favor in a patent infringement proceeding against Occlutech (Jena, Germany). The suit was brought by AGA in 2006 in Dusseldorf, Germany, seeking to enjoin Occlutech from infringing the German part of AGA's European patent (EP 0 808 138) and for resulting damages.

The company said the amount of damages and other remedies will be decided in enforcement proceedings in the near future.

Following the District Court's decision in July 2007, requiring destruction of the infringing product and the entry of an injunction, Occlutech appealed the ruling and introduced its Figulla N product, which it maintained was non-infringing.

AGA said the appeals court not only affirmed the findings of the District Court, but also found that the Figulla N occluder was not materially different from Occlutech's original product, and thus subject to the injunction and resulted in damages to the U.S. firm.

The appeals court further has declined Occlutech's request to stay the infringement proceedings in light of parallel invalidity proceedings pending at the Federal Patents Court.

"The positive ruling of the German appeals court confirms our rightful ownership of this technology and supports the original ruling that Occlutech's products are a clear infringement on our intellectual property," said John Barr, president/CEO of AGA Medical.

3-year Italian accord for Misonix

Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic medical device technology that in Europe is used for the ablation of tumors and worldwide for other acute health conditions, has entered into a three-year distribution agreement with Alliance Lithomobile, a division of Alliance Medical (Milan, Italy).

This agreement supersedes an interim agreement reported in early November.

Under the agreement, Lithomobile will emphasize the Sonablate 500 High Intensity Focused Ultrasound (HIFU) System as a mobile, fee-for-use service to hospitals throughout Italy. Alliance Lithomobile also will be responsible for capital sales of the Sonablate when appropriate. The Sonablate is a HIFU instrument used for the trans-rectal ablation of tumors of the prostate gland.

Misonix and Alliance Lithomobile will share the fee-for-use revenues for the length of the agreement plus an additional three years.

Alliance Lithomobile is well known in Italy as a leading distributor of mobile lithotripsy services, as well as representing capital equipment for oncology and other medical specialties.