Possis Medical has received marketing approval from the FDA for its new AngioJet Ultra Thrombectomy System. Ultra is the next-generation, completely re-engineered version of Possis' proven, AngioJet Rheolytic Thrombectomy System. AngioJet is marketed for thrombectomy from arterial and venous blood vessels. According to the company, the new Ultra System features a simple and fast set-up process, the flexibility to use a broad range of catheters, a sleeker design, lighter weight, and handling improvements that make it significantly easier to manoeuvre than the previous AngioJet drive unit.
Features of Ultra System include:
• A simple set up process compared with the original AngioJet drive unit that required 20 steps in the set up process; Ultra's advanced microprocessor design automatically performs most of the set-up steps by reading a bar code located on each disposable thrombectomy set. The few remaining steps are intuitive and require minimal user training.
• Flexibility to use a broad range of catheters; the Ultra System provides the ability to use a wide range of catheters, both existing as well as those in development, and the system's flexibility promotes the design of new catheters.
• Sleeker design and lighter weight; with its updated design, Ultra is 46% lighter than the previous AngioJet drive unit and its compact, ergonomic design make it significantly easier to move around the hospital.
According to Possis, Ultra features an advanced control system with easier, more intuitive commands. Ultra also allows the physician to easily switch to Possis' patented Power Pulse delivery when necessary, simultaneously delivering clot-dissolving drugs while removing blockages from the affected arteries and veins.
"The Ultra System, which is easier to use and offers much broader catheter flexibility, marks the next step in Possis' evolution, and provides the long-term growth platform for our AngioJet business. The Ultra System's significant enhancements enable physicians to more efficiently perform potentially life and limb-saving thrombectomy procedures," commented Robert G Dutcher, chairman, president and CEO. "We also expect the system's ease-of-use to increase catheter utilisation and provide a far more versatile platform to support the development of new, more specialized and sophisticated catheter models," he added.
The company claims that in the US alone, 95% of top coronary labs have Possis' AngioJet System; in total there are more than 1,700 systems installed across the country. According to Dutcher, Possis currently estimates its total realisable market opportunity for AngioJet thrombectomy in the US at US$440 million, increasing to US$675 million by 2010. Possis will conduct market evaluations of the Ultra System at key sites throughout the US. A full-market release is anticipated by Summer 2007.
The company has also received 510(k) clearance from the FDA for its new Fetch Aspiration Catheter. Utilising catheter technology from the company's premier AngioJet Rheolytic Thrombectomy System, the Fetch Aspiration Catheter offers physicians another alternative for the aspiration of small, fresh blood clots (thrombus) and other embolic debris from arteries.
According to Possis, the rapid exchange Fetch Aspiration Catheter uses an industry-standard syringe as its aspiration source. To provide the flexibility and handling that interventional procedures require, Fetch features an advanced braided shaft design used in other AngioJet thrombectomy catheters marketed by Possis. Additionally, the Fetch catheter is 0.014" guidewire and 6F guide catheter compatible.
Possis will market the Fetch Aspiration Catheter in the Unites States through the company's sales organisation and internationally through an established network of Possis distributors. Anticipated revenue from Fetch catheter sales is reflected in the company's current guidance.
Date: Jan/2007
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