Whereas over 5 million endovascular procedures are carried out within the U.S. annually, Microbot says lower than 1% are achieved robotically. | Supply: Microbot Medical
Microbot Medical right this moment introduced its Liberty endovascular surgical robotic earned 510(ok) clearance from the U.S. Meals and Drug Administration (FDA). The corporate claimed this makes Liberty the primary FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures.
“Acquiring FDA 510(ok) clearance for Liberty marks a defining second for Microbot Medical and, we consider, for the way forward for endovascular robotics. This achievement validates our mission to broaden entry to superior robotic applied sciences whereas addressing important unmet wants and supporting cost-effective healthcare,” Harel Gadot, chairman, CEO, and president of Microbot Medical, stated.
“With our industrial readiness technique being developed and executed since Q2 this 12 months, we consider we’re well-positioned to speed up market entry. With FDA clearance, we are able to now full the ultimate industrial actions that had been contingent on advertising clearance, positioning us to begin commercialization, penetrate the roughly 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into international markets,” he continued.
The FDA clearance positions the corporate to commercialize Liberty within the U.S. The Liberty pivotal examine confirmed 100% success within the robotic navigation to focus on, and nil device-related opposed occasions, Microbot stated. The examine additionally confirmed a 92% relative discount in radiation publicity for physicians.
Microbot plans for wider functions sooner or later
Microbot stated Liberty is an endovascular robotic system for interventional physicians and hospitals looking for to enhance procedural precision, security, and effectivity. Not like conventional guide strategies, Liberty gives a single-use, compact resolution that permits managed distant operation.
The surgical robotic can be utilized in neurovascular, cardiovascular, and peripheral vascular procedures. The system features a compact design and distant working capabilities. Microbot additionally claimed that Liberty has the potential to decrease process prices, improve process effectivity, and enhance the general high quality of care.
In August, Microbot introduced a brand new patent protecting a modular robotic surgical system. The system features a base and a plurality of tool-receiver items organized as separate items. These items are independently and interchangeably attachable to the bottom. The corporate stated the patent will doubtlessly allow it to adapt Liberty sooner or later for a wider vary of endovascular procedures.
With the most recent patent, Microbot now has 12 patents globally and 57 patent functions pending. Microbot Medical is a pre-commercial-stage medical know-how supplier. It stated its imaginative and prescient is to enhance the standard of take care of thousands and thousands of sufferers and suppliers globally. The Braintree, Mass.-based firm stated Liberty is step one towards its purpose of rethinking how robotics can profit healthcare.
Surgical robotics will on the agenda at RoboBusiness, which takes place Oct. 15-16 in Santa Clara, Calif. Iman Jeddi, Ph.D., senior vp and normal supervisor of Intuitive’s multiport platform, will supply a uncommon look contained in the redesign and launch of the da Vinci 5, the firm‘s next-generation surgical robotics system.
