COLORADO SPRINGS, Colo., July 27 -- The Spectranetics Corp. has received the approval of the Food and Drug Administration to market its smallest Point 9 catheters with higher laser parameters (i.e., more laser energy). Bench studies and clinical experience in Canada demonstrated to the FDA that some difficult-to-treat lesions -- some that could not previously be treated in a minimally invasive fashion -- can be safely and effectively treated with higher laser parameters delivered through the company's smallest and most maneuverable catheters.
"We were delighted to receive FDA approval for the modified Point 9 catheters so quickly," said Joseph A. Largey, president and CEO of Spectranetics. "Before they can be used, various upgrades must be performed on different generations of CVX-300 lasers in the field. We initially plan to test market the laser upgrades and higher-performance catheters in a small number of accounts."