A Medical Device Daily

Hansen Medical (Mountain View, California), a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, reported that it has entered into joint development and co-marketing agreements with St. Jude Medical (St. Paul, Minnesota) to integrate technologies from its Sensei robotic catheter system and Artisan control catheter with St. Jude Medical's EnSite system.

The first generation robotic platform from Hansen is designed to allow physicians to place mapping catheters in hard-to-reach anatomical locations within the heart more easily, accurately and with greatly increased stability as compared to existing manual technique. The Sensei has received the CE mark in Europe, and the Artisan catheter is currently pending CE mark approval. Additionally, the Sensei system is awiating FDA clearance.

The EnSite system is a computer-based technology marketed worldwide that facilitates EP procedures by creating real-time 3-D graphical displays or maps of cardiac structures and arrhythmias. These maps are designed to provide the visual guidance necessary to navigate catheters used during EP procedures. Previously, two-dimensional technologies such as fluoroscopy or ultrasound were used to assist physicians with guiding catheters inside the heart, which is a three-dimensional space. Combining the Sensei and EnSite technologies is intended to provide physicians with 3D visualization that will augment their ability to confidently move a catheter throughout the heart, as well as greatly increase control over placement of the catheter in specific locations.

"This joint development agreement facilitates an advanced level of integration of the Sensei system with one of the market-leading 3D mapping technologies for EP," said Frederic Moll, MD, founder/CEO of Hansen Medical. "Integration of the Artisan catheter within the EnSite system's 3-D map will give physicians the ability to move the catheter deliberately and accurately while seeing specifically, in three dimensions, the location of the catheter inside the heart. This is an important step toward achieving automation of EP procedures, which we believe is key to providing clinicians of varying skill levels the ability to more effectively and safely treat complex cardiac arrhythmias."

In addition to lessening operator fatigue, the remote placement of the workstation is intended to create a virtual shield for physicians against harmful radiation during catheter-based EP procedures.

The EnSite System is used by EP clinicians during EP procedures to create 3D models of their patients' cardiac anatomy and then to visualize catheters used in those procedures as they are navigated to critical anatomical targets. The system collects and organizes activation and voltage data from the inner surface of the heart, which allows physicians to visualize arrhythmias on the 3D model and more easily determine a treatment strategy.

Hansen Medical was founded in 2002 to develop products and technology using robotics for the accurate positioning, manipulation and stable control of catheters and catheter-based technologies.

In other agreements: Invitrogen (Carlsbad, California) and Cytori Therapeutics (San Diego) entered into a global supply and commercialization agreement to offer adipose-derived stem cell-based research products to life science researchers. Invitrogen will offer Cytori's stem cell products to broaden the understanding of adult stem cells and to discover and accelerate development of preclinical applications for adipose derived stem cells.

Adipose tissue is widely recognized as a rich source of adult stem cells, according to the companies. A growing number of scientists are performing adipose stem cell research accounting for more than 300 scientific papers and abstracts since the seminal scientific paper describing this cell population was published in 2001. In addition, multiple clinical trials are underway globally using adipose stem cells.

"This product offering provides life science researchers access to an important and validated stem cell population," said Joydeep Goswami, PhD, VP of stem cells and regenerative medicine for Invitrogen. "Adipose derived stem cells represent an attractive cell source from which to conduct regenerative medicine research, and we are excited to enter into this partnership with Cytori, a pioneer in this field."

Invitrogen products and services are intended to support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides technologies for disease research, drug discovery, and commercial bioproduction.

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