Hansen Medical (Menlo Park, California) hit the ground running this week with the introduction of three products set to bolster its place in the robotic electrophysiology market. The company reported gaining FDA approval for its next generation Sensei X robotic catheter system and approval for its Artisian Extend control catheter for mapping procedures in the atria. The company also reported the introduction of its Lynx robotic abalation catheter.
"We actually received word as of Friday that both the Sensei X system and the Artisan Extend control catheter had been cleared by the FDA, Robert Mittendorff MD, senior director, marketing and business development at Hansen Medical told Medical Device Daily. "We think this is an improvement over our previous iterations and the system has extra features."
The company says that the new Sensei X platform provides physicians with improved procedural planning and workflow, and enhancements in catheter control within the heart during EP procedures. Software for the system actually gives the surgeon the ability to view the patient's heart endoscopically or through endoview which provides a real time map of the heart through an endoscope.
"We develop a pretty good list of clinical needs when we're developing new products," Mittendorf said. "The ability to have that endoview option using the system was one of those needs."
The Artisian Extend is being touted as being more flexible and more nimble than previous iterations.
According to Amin Al-Ahmad, MD, Assistant Professor of Cardiology, Stanford University Medical Center (Stanford, California), who evaluated the Artisan Extend catheter, "The improved flexibility and bend radius with the Artisan Extend catheter allows access to the right inferior pulmonary vein and other cardiac targets that are typically harder to reach when mapping with manual technique. In addition, the set up for the new catheter is simplified, so our procedure time will be reduced."
The new Lynx robotic ablation catheter, which the company plans to launch in the European market, is supported by the Sensei X platform and leverages the navigation capability of the Artisan Extend catheter, but in a smaller and more flexible integrated profile for the treatment of atrial fibrillation (AF) and other electrophysiology disorders.
Offering a 7 French irrigated ablation tip with a standard sized sheath, the new Lynx catheter has six degrees of freedom that facilitates placement in difficult to reach anatomic locations.
Plans call for the company to begin shipping the Sensei X system in 3Q09 in the U.S. and in Europe. The company will begin shipping the Artisan Extend catheter around the same time and said that it expects that the catheter will receive the C.E. mark in the 4Q09.
Eventually Mittendorff said the company could try and get the FDA to approve the device for more designations – beyond just mapping procedures in the atria, but he declined to say what those designations could be.
The Lynx robotic ablation catheter will be available in Europe upon receipt of the CE mark, which is expected in the first half of 2010. However the company said that there were no current plans to bring the Lynx robotic catheter to the U.S.
The Lynx robotic ablation catheter will be showcased for the first time at Venice Arrhythmias 2009, a biannual international workshop on cardiac arrhythmias held in Venice, Italy, Oct. 4-7.
Hansen has been experiencing a great deal of forward momentum this year. In April, the company reported pricing a public offering of 11,692,000 shares of its common stock at a price to the public of $3.25 per share (Medical Device Daily, April, 20, 2009). The gross proceeds to Hansen Medical, before expenses, from the sale of shares would be about $38 million. Piper Jaffray & Co. (Minneapolis) was the sole manager for the offering.
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