Amigo in Clinical Use

Transcription

1 Amigo in Clinical Use

2 Amigo in Clinical Use Study Overview The purpose of this clinical investigation was to demonstrate the safety navigation performance of Amigo. 206 patients were enrolled at 13 centers data was collected evaluated on safety, efficacy, the learning curve of Amigo. Safety Results Safety was determined by: No Major Complications No unanticipated Adverse Events No Perforations Navigation Performance Using the remote controller, the catheter was advanced to 8 pre-specified locations in a specific sequence. Time to each location, location accuracy quality of contact was confirmed by imaging with specific criteria for electrograms pacing thresholds. A point was considered a success if all required data was collected. A total of 1448 locations were mapped. Navigation Success Rate Amigo Technical Specifications Parameter Success Rate Efficacy 96% Efficacy adjusted for missing source data 97% Efficacy using floroscopic confirmation only 99% Responder Success (6/8 locations successful) 98% Physician Evaluation After each procedure, the physician filled out a questionnaire related to ease of use of Amigo catheter control with Amigo. In 92% of first cases, investigators found Amigo easy to operate In 98% of subsequent cases, investigators found Amigo was easy to operate. Learning Curve The average manipulation time required to reach a location was 45 seconds. The first proceedure had the longest average manipulation time but a statistically significant decrease occurred by the 3rd use. Physician learning curve was only associated with proficiency in using Amigo not with complications. Navigation Times 1.5 Average Manipulation Time per Location (Minutes) Number of Cases Mean Manipulation Time All data based on Amigo IDE Clinical Trial (NCT ) Catheter Robotics, Inc. 500 International Drive Mt. Olive, NJ Rev1 Copyright Catheter Robotics, Inc All rights reserved.

3 Amigo Remote Catheter System

4 Amigo Remote Catheter System Amigo Remote Catheter System Amigo is a new generation of robotic catheter systems. It utilizes a simple design a familiar controller. It was developed with three goals in mind: Simple to use Easy to learn Cost effective Safe, Consistent Performance Amigo Technical Specs Amigo Technical Specifications Dimensions (H x W x D) 40 x 54 x 44 inches Weight (approximate) 70 lbs Performance Linear translation < 12 mm/sec ± 2 mm/sec Linear resolution < 1.6 mm Rotation resolution < 1.1 degrees Rotation maximum rate < 0.42 revs/sec Articulation resolution 1.0% full scale Articulation maximum rate 0.48 revs/sec Facility Power Requirements 120 VAC, 60 Hz, 15 amp, 1Ø 230 VAC, 50 Hz, 15 amp, 1Ø 99% of target locations are reached with Amigo 1 0% major complication rate 1 Effortless Learning Navigation Times Requiring less than one hour of practice, no animal labs, Amigo is designed to be easy to learn. There are statistically significant decreases in navigation times after only 3 patients. 1 In 92% of first cases physicians found Amigo easy to use 1 Similar to a catheter hle, the controller is intuitive familiar Seamless Integration Amigo was designed to be cost effective. To achieve this goal, engineers designed Amigo to fit into an existing EP Laboratory with no additional costs. Compatible with existing monitors workstations No room rebuild No proprietary catheters, introducers, or sheaths, maintaining procedure costs Average Manipulation Time per Location (Minutes) Number of Cases Mean Manipulation Time 1 Amigo IDE Clinical Trial (NCT ) Catheter Robotics, Inc. 500 International Drive Mt. Olive, NJ Rev1 Copyright Catheter Robotics, Inc All rights reserved.

5 Controller Disposable Kits

6 Controller Intuitive Control Natural easy to learn 1 Built in safety features Simple catheter control up to 100 feet away Simple, Familiar Design Rotation knob allows for continuous 360 rotation of the catheter in either direction. The Motion Light indicates when the catheter has reached the maximum movement in a particular direction. Deflection knob allows for bidirectional control of the catheter tip. Insert button advances the catheter into the heart. Withdraw button pulls the catheter back to be withdrawn. Ready Light indicates when the system s infrared beam has been activated. 1 Amigo IDE Clinical Trial (NCT ) Catheter Robotics, Inc. 500 International Drive Mt. Olive, NJ Rev1 Copyright Catheter Robotics, Inc All rights reserved.

7 Disposable Kit

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