Healthcare Industry News:  Volcano Corporation 

Devices Cardiology Litigation

 News Release - July 27, 2010

St. Jude Medical Files Patent Infringement Lawsuit Against Volcano Corporation in the U.S.

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, announced today that it has filed a lawsuit against Volcano Corporation for patent infringement. The suit, which involves five St. Jude Medical patents and seeks injunctive relief and monetary damages, was filed in the United States District Court for the District of Delaware.

The patent infringement lawsuit alleges that several products distributed by Volcano, including its PrimeWire™ pressure guide wire products, infringe on key patents used for the St. Jude Medical PressureWire® technology platform, which was acquired from Radi Medical Systems AB in December 2008. The PressureWire interventional technology measures Fractional Flow Reserve (FFR), which is an index used to evaluate the severity of blood flow blockages in the heart. FFR measurements enable interventional cardiologists to better determine the most effective treatment option for their patients during coronary interventions.

St. Jude Medical Systems AB, previously known as Radi Medical Systems AB, is the owner of the entire right, title, and interest in and to each of the five patents involved and is a plaintiff in the lawsuit. Two other St. Jude Medical affiliates are also plaintiffs.

"St. Jude Medical has made significant investments in the interventional cardiology space, including the coronary assessment and more recently the coronary imaging markets,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “From clinical research to important product advancements, Radi Medical Systems and now St. Jude Medical have contributed considerably to the success of this marketplace. As a company that values the innovations we bring to the marketplace, we intend to protect our intellectual property.”

The former Radi Medical Systems AB and now St. Jude Medical have invested millions of dollars in landmark clinical trials, such as the FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) study, that demonstrated superior clinical and cost-effective outcomes of FFR-guided treatment.

The patent lawsuit initiated today follows St. Jude Medical’s recent acquisition of LightLab Imaging, Inc., which is already engaged in litigation against Volcano and its wholly owned subsidiary Axsun Technologies, Inc., a supplier to LightLab. LightLab is a pioneer and leader in the development of Optical Coherence Tomography (OCT) used in coronary imaging procedures. Earlier this year, a jury in the Superior Court of Massachusetts, Suffolk County, reached a verdict against Volcano and Axsun Technologies.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Source: St. Jude Medical

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