Vascular Solutions Inc announced that its PMA Supplement for the Diagnostic Duett sealing device has been approved by the U.S. Food & Drug Administration. The U.S. launch of the Diagnostic Duett has already commenced through the company's 65 person field sales force.

Vascular Solutions also announced that the 510(k) application for its D-Stat flowable hemostat has received a favorable determination from the FDA. This regulatory clearance permits U.S. sales of the D-Stat to commence for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes. The U.S. market launch of the D-Stat through the company's field sales force is planned for mid-February, pending the completion of initial manufacturing builds.

The Diagnostic Duett is a new version of the original Duett sealing device that is tailored for treating diagnostic patients. The procoagulant in the Diagnostic Duett is dosed for the less-challenging diagnostic patients where substantial blood-thinning drugs are less frequently used. This results in a less expensive version of the original Duett device, which is still fully effective for the over 2.5 million diagnostic procedures that occur each year in the United States.

"The introduction of the Diagnostic Duett in the U.S. will allow us to compete more favorably in the cost-conscious diagnostic cath labs while still maintaining a very favorable gross margin," commented Howard Root, CEO of Vascular Solutions. "The Diagnostic Duett was the subject of a 302 patient clinical study, with the results compared to the standard compression arm of the company's seminal SEAL clinical study. The clinical results in the Diagnostic Duett study further re-enforce the excellent clinical outcomes that can be obtained with the Duett approach to sealing," Root commented.

The company's second new product, the D-Stat flowable hemostat, uses the Duett procoagulant components to create a thick, yet easily deliverable, hemostat. The D-Stat consists of the same collagen, thrombin and diluent components as the Duett sealing device, which has been proven effective in controlling bleeding from aggressive arterial puncture sites. After a simple reconstitution step, the D-Stat hemostat can be applied directly to a wide variety of bleeding surfaces using one of the three included applicator tips. The D-Stat is shelf stable and can be prepared up to three hours before use.