FDA: Datascope’s Safeguard Does Reduce Post-Cath Compression Time
March 9, 2007 — Datascope Corp. has received 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 seven 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. The company says that significant economic benefits are realized by using Safeguard, which sharply reduces the amount of nursing labor devoted to post-procedure hemostasis.
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 segment of its sales force.