Spectranetics, a medical device manufacturer of Colorado Springs, Colo., has agreed to pay U.S. government agencies $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims pursued by the FDA and the U.S. Immigration and Customs Enforcement against the company, the Justice Department reported on Dec. 29, 2009.
Spectranetics experienced severe net losses for its fiscal third quarter, which ended Sept. 30.
The FDA has approved Spectranetics' Turbo-Tandem, a single-use, disposable device indicated for atherectomy of infrainguinal arteries. CE mark approval was received earlier this month.
BOSTON—Laser-assisted lead removal demonstrated safety and efficacy, based on initial data from the four-year, retrospective LExICon study presented today at the 30th annual scientific sessions of the Heart Rhythm Society (HRS). However, principal investigator Bruce Wilkoff told Cardiovascular Business News that the greatest differentiator in success rates and patient outcomes depends on operator experience.
Spectranetics has made new two executive appointments for newly created positions. Michael Handley has been promoted to vice president, global regulatory affairs and compliance; and Elaine Messa has joined as interim chief compliance officer.
Spectranetics has obtained FDA clearance for its Cross-Pilot laser support catheter.
Two separate law firms have filed class-action suits in the U.S.
District Court of Colorado against Spectranetics, on behalf of all
persons or entities that purchased or acquired securities or company
stock between April 19, 2007 and Sept. 4 of this year, claiming the
company and its officers violated U.S. securities laws.
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The FDA has granted 510(k) clearance for Spectranetics’ VisiSheath dilator sheath device, which recently received CE Mark approval in Europe.
Refinements to catheters have improved the way they handle, follow the guidewire and navigate tortuous anatomy. Characteristics such as catheter flexibility, the shape and flexibility of the tip, balloon flexibility and joint construction provide the ingredients for optimum deliverability and pushability.
Spectranetics has received the CE Mark approval for its next-generation ThromCat XT thrombus removal system, a single-use, disposable device used to remove the thrombus from native coronary arteries and infra-inguinal arteries.
Despite an increase in net losses for the fourth quarter of 2008, Spectranetics showed increased profits for the 2008 fiscal year, which ended Dec. 31.
Written by David E Allie, MD
Recent studies suggest the staggering clinical and economic costs of critical limb ischemia can be reduced by utilizing newer treatment technologies.
Spectranetics has reported its financial results for the 2008 third quarter, which ended Sept. 30. Simultaneously, the company received a notice from the staff of the Nasdaq Stock Market that it was not in compliance with Nasdaq's independent director and audit committee requirements.
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The use of health IT to reduce rehospitalizations will be welcome but also disruptive, said Stephen Jencks, an independent consultant in healthcare safety during a Feb. 24 webinar on the potential use of health IT to mitigate rehospitalizations, sponsored by the Agency for Healthcare Research and Quality (AHRQ).