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August 26, 2014

Hansen Medical's Magellan Transport System Launched in the United States

August 27, 2014—Hansen Medical, Inc. announced that it has received US Food and Drug Administration 510(k) clearance for a modified rail for the Magellan robotic system. This clearance enables the company to begin commercial introduction of the Magellan transport system, which is designed to move the Magellan robotic arm between procedure rooms for performing robotic endovascular procedures. The company anticipates commercialization of the Magellan transport system in the third quarter of fiscal year 2014. Hansen will also be seeking regulatory clearances to market the Magellan transport system in Europe.

According to Hansen's release, the Magellan transport system facilitates greater utilization throughout a hospital by enabling the Magellan robotic arm to be shared among different procedure rooms that are equipped to support the robotic system, giving access to multiple physician specialties in several settings. The company's clinical support personnel will operate the device during the initial period of commercialization.

Hansen's Magellan robotic system is intended to facilitate navigation in the peripheral vasculature and then provide a conduit for manual placement of therapeutic devices. The system provides predictability, control, and catheter stability to endovascular procedures. It also enables more predictable procedure times and increased case throughput, potentially allowing hospitals to improve utilization within their vascular business line.

The system’s open architecture allows for the subsequent use of many therapeutic devices. It is also designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures.

The Magellan 9-F robotic catheter allows for independent, robotic control of the distal tip of two telescoping catheters (an outer guide and an inner leader catheter), as well as robotic manipulation of standard guidewires. It also allows for independent robotic control of two separate bend sites on a single catheter, as well as robotic manipulation of standard guidewires. This smaller catheter design can be used for a smaller diameter vessel access site or in procedures in smaller vessels, the company said.

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August 27, 2014

WAVE IV Evaluates Kona Medical's Surround Sound Renal Denervation System

August 27, 2014

WAVE IV Evaluates Kona Medical's Surround Sound Renal Denervation System