A Medical Device Daily
Physio-Control (Redmond, Washington), a Medtronic (Minneapolis) subsidiary, said it has reached an agreement on a consent decree with FDA regarding its quality system improvements for its external defibrillator products.
According to the company the agreement was filed Friday in the U.S. District Court for the Western District of Washington and is subject to that court's approval. Physio-Control said the agreement addresses issues raised by FDA during inspections regarding the company's quality system processes and outlines the actions Physio-Control must take in order to resume unrestricted distribution of its external defibrillators.
The company declined to discuss the specifics of the agreement for Medical Device Daily.
In December Physio-Control said it planned to resume full shipments of its defibrillators by April 30 and that it was making progress toward improving previously reported problems.
The company suspended shipments to U.S. customers in January 2007, citing vague concerns about quality-control systems. A few weeks later, it eliminated 300 jobs, or about 30% of its workforce.
The shipment suspensions served to delay a planned spin-off of Physio-Control by Medtronic that was first disclosed in December 2006.
"During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution," Brian Webster, president of Physio-Control, said in a company statement. "We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations."
In the meantime, worldwide shipments to meet customer requirements and certain specified public health needs will continue, Physio-Control said.
Physio-Control makes Lifepak brand defibrillators.
In other legal action: Spectranetics (Colorado Springs, Colorado) said it has settled its intellectual property dispute with Medtronic and that Medtronic has taken a license to the patent at issue in the litigation.
Terms of the settlement agreement were not disclosed.
"We are pleased to reach this settlement with Medtronic. This license validates our strong intellectual property position in the area of thrombus management with aspiration catheters," said John Schulte, Spectranetics president/CEO in a company statement.
Spectranetics makes an excimer laser approved in the U.S., Europe and Japan for use in minimally invasive cardiovascular procedures. The technology is designed to treat complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the bloodstream.
The company said its disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads.