A Medical Device Daily

AGA Medical (Golden Valley, Minnesota) reported enrollment of the first patients in its newest clinical trial - PRIMA (Patent foramen ovale closure Reduction In Migraine with Aura) - intended to examine the connections between certain types of migraine headaches and a heart defect found in more than 20% of all adults. The first patients were enrolled at the Swiss Cardiovascular Center Bern, University Hospital (Bern, Switzerland).

PRIMA is a prospective, randomized, two-arm, multi-center trial to determine whether patients who undergo closure of a PFO with the company's Amplatzer PFO Occluder device have a reduction in both the number and severity of certain types of migraine headaches. The study is expected to enroll about 120 patients at up to 10 medical centers in Europe.

Heinrich Mattle, MD, deputy chairman of the department of neurology of the university hospital in Bern and principal neurologist investigator for PRIMA, said that the trial "is designed differently than the previous PFO Migraine trials in that the endpoint is a more appropriate 50% reduction of migraines in 50% of the patients. Additionally, the roll-in phase is longer, the follow-up treatment phase is longer, and neurologists are important investigators in the trial."

About 11% of the population suffers from migraine headaches, and observational studies have reported a significant number of patients experience a reduction in the frequency and severity of migraine headaches following closure of a PFO.

Trial neurology and cardiology specialists will select migraine patients with aura, a headache with pain that is accompanied by flashing lights, vision loss, and other temporary neurological deficits. They will provide randomized treatment of either PFO closure with the Amplatzer PFO Occluder, or medical treatment. This randomized trial is designed for comparative evaluation of the effectiveness of PFO closure in migraine reduction.

The Amplatzer PFO is implanted via a catheter inserted in the patient's groin. The procedure typically takes as little as 15 minutes by experienced physicians, and the patient is back to normal lifestyle in less than 24 hours.

PRIMA is one of two AGA Medical-sponsored studies exploring the link between PFO holes and certain types of migraine headaches. The other study is taking place in the U.S.

Boston Sci files suit vs. Conor Medsystems Ireland

Boston Scientific (Natick, Massachusetts) yesterday said that it has filed a lawsuit in Ireland against Conor Medsystems Ireland (Athlone, Ireland), charging that the Conor CoStar Paclitaxel-Eluting Coronary Stent System infringes a balloon catheter patent owned by Boston Scientific.

Boston Scientific is asking for damages and an injunction to prohibit Conor from making, offering, putting on the market or stocking the product in Ireland.

The U.S. company said that the asserted patent "is the Irish counterpart of the European patent that Boston Scientific has successfully asserted against Johnson & Johnson [New Brunswick, New Jersey] in the Netherlands."

Staar, IDev win CE marks

Two companies reported garnering CE marking for their products this week:

• Staar Surgical (Monrovia, California) reported receiving the CE mark for its preloaded aspheric silicone IOL (intraocular lens). The approval will allow Staar to market the aspheric silicone IOL for use in cataract surgery in 21 countries.

Staar says that the KS-3Ai is the world's first preloaded IOL injection system to offer an aspheric optic design, which has a more complex surface profile designed to eliminate spherical aberrations and reduce the other optical aberrations that can occur in conventional spheric lenses. The aspheric lens is designed to be delivered through an incision size smaller than 3mm, an important criterion for minimally invasive cataract surgery.

This new product is the latest development in the world's first line of preloaded IOLs, introduced into international markets in 2003 through Staar's Swiss affiliate, Staar AG. The KS-3Ai includes the lens, cartridge and injector body in a single, disposable pre-sterilized unit, offering ease, safety and convenience and providing a controlled sterile pathway directly into the eye.

Staar's preloaded IOLs are not yet approved for use in the U.S.

David Bailey, president and CEO of Staar Surgical, said, "Aspheric lenses are quickly becoming the standard of care and we believe the features of our easy-to-use preloaded delivery system will allow us to gain market share in this growing segment. Our preloaded silicone IOL has grown significantly in international markets and as of the first quarter 2006, represented 18% of Staar's total IOL sales.

He said the product will be officially launched to international markets during the joint annual meeting of the Italian Association of Cataract and Refractive Surgery/Italian Society of Ophthalmology in Rome, May 17 - 20. At this meeting Scipione Rossi, MD, San Carlo Hospital will perform the first Live Surgery with the product. Staar will then begin shipments to distributors during the first week of June.

• IDev Technologies (Houston), a developer of minimally invasive stent systems for the treatment of peripheral vascular and non-vascular diseases, reported receiving CE mark approval for the design, development and manufacture of stent devices for removal of inadvertently dislodged or misplaced objects from peripheral body vasculature, for palliative treatment of biliary strictures produced by malignant neoplasms and for use in peripheral vasculature for failed PTA.

The IDev stent is described as a self-expandable nitinol device "with significant radial force that is resistant to kinking, crushing and fracture potential." Its delivery system "allows for precise placement and repositionability prior to deployment."

Thomas Tully, CEO and chairman of IDev, said that CE marking is the first step toward worldwide commercialization of the company's stent.

He added: "The company is initially preparing a limited distribution strategy to elite interventional centers throughout Europe," targeting 2.5 million patients who suffer from critical limb ischemia.

The company said it is preparing to launch the product in Europe "shortly."