A Medical Device Daily

Diomed Holdings (Andover, Massachusetts), a developer and marketer of minimally invasive medical technologies, said that U.S. District Judge Nathaniel Gorton has granted Diomed a permanent injunction against both AngioDynamics (Queensbury, New York) and Vascular Solutions (Minneapolis) based on Diomed’s U.S. Patent Number 6,398,777 regarding the endovascular laser treatment of varicose veins.

Gorton adopted Diomed’s proposed order, granting a permanent injunction against AngioDynamics’ and Vascular Solutions’ infringing products and any other products that are no more than “mere colorable variations.”

The injunction prohibits AngioDynamics from selling its VenaCure bare tipped fiber, used in a minimally invasive therapy for severe varicose veins.

“We are extremely pleased with Judge Gorton’s ruling which prohibits the defendants from promoting, marketing and selling their laser consoles or any disposable products that are used in the endovenous treatment method covered by our patent,” said James Wylie, president/CEO of Diomed. “[The] ruling is a huge win for Diomed. If the defendants’ recently modified products are mere colorable variations of those already determined to infringe, then we will be in a position to file a motion for a finding of contempt of court. Alternatively, if the devices do not permit contact between the fiber tip and the vein wall, then there is no long-term clinical evidence that such alternative approaches will deliver sustained vein closure.”

In January 2004, Diomed began legal action in the U.S. Federal District Court for the District of Massachusetts against AngioDynamics, seeking injunctive relief and damages for infringement of Diomed’s pioneering “777” patent. Diomed initiated similar infringement actions against Vascular Solutions and two other competitors later in 2004. In August 2006, Judge Gorton ruled that Diomed’s ‘777 patent is both valid and enforceable and, in the trial ending on March 28, the jury found AngioDynamics and Vascular Solutions liable for both inducing infringement and contributory infringement of Diomed’s patent, awarding Diomed a total of $12.4 million in damages. The parties have also stipulated to an additional $2.2 million representing prejudgment interest and post-judgment sales that will be added to the damages awarded by the jury (Medical Device Daily, March 30, 2007).

“Normally, when a medical device company introduces a new product or procedure, the launch is based on extensive testing and sound clinical data,” the company said. “Any new product that is claimed to avoid contact between the fiber and the vein wall should be viewed as an entirely new procedure and thus should be subject to the same levels of clinical scrutiny as EVLT when it was first introduced. Diomed believes that the defendants’ latest products were brought to market with only one objective apparently in mind — an attempt to get around our patent, and not because they offer proven advantages to the physician or better outcomes for the patient.”

Diomed develops minimal and micro-invasive medical procedures that use its laser technologies and disposable products. Diomed’s EVLT laser vein ablation procedure is used in varicose vein treatments. Diomed also provides photodynamic therapy for use in cancer treatments, and dental and general surgical applications.

AngioDynamics said it had stopped selling the disposable kits in April. Since June 2, the company has been selling only the new NeverTouch VenaCure disposable kits and laser consoles for use with such kits, AngioDynamics said. The NeverTouch VenaCure employs a gold-coated spacer component over its laser fiber tip, a new generation of technology designed to further eliminate inadvertent contact between the laser-emitting end of the fiber and vessel wall during treatment. NeverTouch represents an advance over AngioDynamics’ first generation bare tipped VenaCure through its provision of an enhanced level of protection against vein wall perforation during laser therapy, the company said.