Possis Medical gets FDA OK to market catheter
April 4, 2007 (SmallCapInvestor.com) – Possis Medical Inc. (Nasdaq: POSS) said late today that it has received the green light from federal regulators to market its Spiroflex VG catheter.
Now, Minneapolis-based Possis will be able to market the AngioJet Spiroflex VG rapid exchange catheter for use in bypass grafts in the heart and larger native coronary vessels. Specifically, the device has been approved for coronary blood clot (thrombus) removal.
Blood clots in coronary arteries and bypass grafts can cause lack of oxygen in the heart muscle and may lead to a heart attack. The AngioJet system was developed to quickly restore necessary blood flow.
The U.S. Food and Drug Administration (FDA) also approved the AngioJet in July 2006 for removing clots in larger peripheral arteries. It already is marketed for peripheral arterial use in Europe and other international markets.
Today’s approval marks the fourth the company has received from the FDA in the past several months, the medical device company said.
In December, the FDA approved the marketing of the company's AngioJet Ultra Thrombectomy.
Also, in late November, the FDA gave Possis the go-ahead to market its Xpeedior catheter, which is used with its AngioJet system.
News of the most recent FDA approval sent Possis’ stock soaring by $2.01, or nearly 16%, to a new 52-week-high of $14.92 on heavy volume in after-hours trading today. Prior to today, the company’s shares had traded as high as $14.02 – on Feb. 8 – and as low as $7.72 – on June 12 -- in the past year.
