FDA News

Datascope's Safeguard Gets FDA Approval

(March 08, 2007)--Datascope said that it has FDA 510(k) clearance to claim that its Safeguard manual compression assist device reduces active (manual) compression time needed to stop bleeding following femoral arterial catheterization in diagnostic and interventional procedures.

The 510(k) included data from a controlled clinical trial of 100 patients at the Indiana Heart Hospital and St. Mary's of Michigan, which showed that Safeguard reduced the time of manual compression needed to stop bleeding in diagnostic patients to an average of 7 minutes from an average of 29 minutes using manual compression alone (the controls). For interventional patients, Safeguard reduced manual compression time needed to stop bleeding to an average of 10 minutes compared to an average of 27 minutes using manual compression alone. By sharply reducing the amount of nursing labor devoted to post-procedure hemostasis, Safeguard adds a significant economic benefit to its use.

"We believe Safeguard will benefit patients and clinical staff in the more than 50 percent of cardiac and peripheral catheterization procedures that use manual compression to achieve hemostasis," said Bill Friedberg, Vice-President of Marketing and Sales of Datascope's Cardiac Assist division. "In the U.S. alone, about 50% of the four million cardiac catheterization procedures each year use manual compression to stop post-procedure bleeding. In international markets, an even greater percentage of an estimated two million procedures use manual compression in order to reduce costs," added Friedberg. "We believe that Safeguard's newly proven economic benefit should significantly strengthen our competitive position in an estimated $125 million potential annual world market."

Safeguard is currently being sold by a relatively small but dedicated direct sales force. Beginning July 2007, Datascope plans to more than triple the Safeguard sales force by adding Safeguard to the product portfolio of the entire Cardiac Assist sales force.

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