Study Highlights Potential for Improvements With Hansen Medical's New Robot

[Bobby.Gray]

Hansen Medical, Inc. (NASDAQ: HNSN) announced the successful completion of a pre-clinical in-vivo study evaluating its new vascular robot, which demonstrated improvements in catheter navigation, reductions in vessel trauma during catheter manipulation, and improvements in access time for some vessels, as compared to manual catheter manipulation during endovascular procedures. Results also showed that the company's vascular robot has the potential to standardize catheter navigation, which may lead to more predictable procedures. The early, but encouraging results were presented June 12, 2010 at the Society of Vascular Surgery's 2010 Vascular Annual Meeting in Boston.

The pre-clinical in-vivo study was performed under the guidance of Alan Lumsden, M.D. and Jean Bismuth, M.D., from the DeBakey Heart & Vascular Center at Methodist Hospital in Houston. The study endpoint was safe cannulation (insertion of a catheter into a branch vessel) and deployment of balloon and stent in the contralateral superficial femoral artery, the renal artery, and the mesenteric arteries. Safety was evaluated through both gross visual examination and histopathology of target vessels, and angiographic evidence of trauma.

"Our in-vivo experience using Hansen Medical's new vascular platform demonstrated that robotic catheterization has the potential to be less traumatic to vascular anatomy when compared to manual catheterization," said Dr. Bismuth, assistant professor, Methodist Hospital, Houston. "This is based on recent work we performed showing reductions in vessel trauma observed on histological evaluation of arteries accessed robotically in comparison to those accessed manually. In addition, these results demonstrate that the use of this vascular robot may reduce harmful radiation exposure to both the patient and clinician."

The pre-clinical study featured the use of a new, smaller vascular robotic catheter, which incorporates a removable, robotically shapeable diagnostic catheter inside of a 6 French (1 French = 1/3 mm) robotically shapeable sheath for delivery of therapeutic devices. Specifically, a single vascular catheter was able to successfully navigate the aorta and access several primary and secondary branches. Additionally, three stents were successfully delivered through the 6 French robotic sheath in several target vessels.

According to Dr. Bismuth, "The smaller size of the catheter lends itself to a large number of vascular applications, and the new Hansen Medical vascular robot has the potential to improve the learning curve for operators."

"We are extremely encouraged by the results of this pre-clinical in-vivo study, as this accomplishment brings us one step closer to the introduction of a new Hansen Medical robot and catheters for use in the vascular system," said Robert Mittendorff, M.D., vice president of marketing and business development. "We believe our new robot and its clinical capabilities for complex vascular procedures will open up significant, new opportunities for Hansen Medical in the near future."

Hansen Medical's flexible robotic technology provides physicians with the ability to precisely manipulate catheters using advanced three-dimensional controls and visualization. Hansen Medical continues to develop and advance flexible robotics technology for applications including vascular and interventional medicine. The Hansen Medical vascular robot has not received regulatory clearance and is currently not available for sale.

About Hansen Medical, Inc.

Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The company's robotic navigation system enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during complex cardiac arrhythmia procedures. Hansen Medical's Sensei(R) system and its Sensei X Robotic Catheter System are compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. The remote navigation platform was cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in Electrophysiology (EP) procedures. The safety and effectiveness of the Sensei and Sensei X systems for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established. In the European Union, the Sensei and the Sensei X systems are cleared for use during EP procedures, such as guiding catheters in the treatment of AF. Additional information can be found at www.hansenmedical.com.