A Medical Device Daily

With more than 14,000 attendees expected from 60 countries, it is no wonder device makers seem to flock to the Heart Rhythm Society's (HRS; Washington) annual meeting to showcase new arrhythmia care products.

Among the companies using the organization's 29th annual scientific sessions as a stage for unveiling new devices is Cook Medical (Bloomington, Indiana), which introduced its Evolution-Shortie mechanical dilator sheath set yesterday at the meeting in San Francisco.

Cook said the sheath set is a natural adjunct to its Evolution mechanical extraction sheath technology. The enhanced technology is designed for venous entry during cardiac lead extraction procedures. It is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, in-dwelling catheters and foreign objects.

Cook says the Evolution-Shortie offers "the same intuitive and well-received Evolution mechanical dilator system technology, with added features designed to simplify vessel access during the lead extraction procedure." The device employs a shorter length to enhance physician control and a specialized distal tip that enables physicians to succinctly negotiate through tough fibrous binding adhesions, according to the company.

"Physicians have historically been forced to rely on either laser powered or mechanical extraction sheaths for difficult vein entry maneuvers," said Barry Norlander, global marketing manager for Cook Vascular, the maker of both Evolution devices. "If vein access cannot be accomplished with an extraction sheath, the physician must decide to either abort the procedure or use a less-desirable alternate extraction approach. With the Evolution-Shortie, physicians have access to an advanced tool that allows for a more effective procedure, resulting in a significant reduction in time, effort, cost and inconvenience to the patient."

Cook said the Evolution-Shortie is available in 9 Fr and 11 Fr inner diameter sizes.

Also at HRS, Hansen Medical (Mountain View, California) said its Sensei Robotic catheter system will be featured in 13 clinical presentations this week.

The Sensei is a robotic navigation system designed to enable clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during complex cardiac arrhythmia procedures. The Sensei system is compatible with fluoroscopy, ultrasound, 3-D surface map and patient electrocardiogram data and was cleared by FDA about a year ago (Medical Device Daily, May 14, 2007).

"We continue to be pleased by the demand for our technology and the clinical experience gained with the Sensei system," said Frederic Moll, MD, co-founder and CEO of Hansen Medical. "Due to the fact that several of our installed sites no longer require clinical support from us, we aren't able to track every case completed. However, we are aware of a minimum of 600 procedures performed using our system for remote navigation, and we are confident the adoption of this technology in the treatment of complex cardiac diseases will continue to grow."

According to the company, some clinicians using the robotic technology are reporting high levels of confidence and less operator fatigue. Physicians of differing skill levels are able to use the Sensei system within their practices, Hansen Medical noted. Additionally, certain physicians in the European Union are able to combine the use of the Sensei systems' remote navigation capability with irrigated catheters to deliver more effective therapy during complex cardiac procedures, the company said.

The CoHesion 3D Visualization Module, an integrated product that combines the 3-D visualization of the EnSite visualization system from St. Jude Medical (St. Paul, Minnesota) with 3-D navigation from the Sensei system, has been released in the European Union.

There currently are six European Sensei systems configured with the CoHesion Module and some physicians already are reporting lower fluoroscopy time and increased confidence in their ability to navigate percutaneous catheters within the heart, Hansen Medical said.

FDA clearance for the integrated system is expected by mid-2008.