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RECENT NEWS (click item to open/close story)

Catheter Robotics Announces FDA Approval

Catheter Robotics, Inc. is pleased to announce the additional 510(k) clearance by the Food and Drug Administration (FDA) of Amigo™ catheter for use with the EZ STEER™ diagnostic catheter handle made by Biosense-Webster. Catheter Robotics recently entered the US market with right-sided diagnostic approval for the diagnostic catheter, Blazer® DX – 20 catheter (Boston Scientific).

Amigo™ is a remote catheter system that allows physicians to operate a catheter up to 100 feet from the radiation field, allowing the physician protection from radiation. It is designed to be compatible with third-party catheters and to easily integrate into a hospital's existing electrophysiology lab. When placed on the Amigo system, the catheter is navigated by remote control that mimics the catheter handle, reducing the time needed for physicians to feel comfortable using a robotic catheter system.

"We are pleased to provide physicians with another catheter combination for Amigo. The wonderful thing about Amigo is that it is an open platform device, allowing the physician to select their preferred catheter. Having this approval should increase interest from physicians who use the Biosense-Webster EZ STEER™ catheters and help Catheter Robotics gain strength in the robotic market," said David Jenkins, President and CEO. "By allowing physicians to use the catheter of their choice, we are meeting a need that has not been met by other robotic companies."

 
Catheter Robotics Receives 510(k) Clearance of Its Amigo™ Remote Catheter System

Catheter Robotics, Inc. is pleased to announce 510(k) clearance of Amigo™ by the Food and Drug Administration (FDA). Catheter Robotics will enter the US market with right-sided diagnostic approval with the Blazer® DX 20 catheter (Boston Scientific).

Amigo™ is a remote catheter system that allows physicians to operate a catheter some distance from the radiation field, up to 100 feet. It is designed to be compatible with third party catheters and to easily integrate into a hospital's existing electrophysiology lab. When placed on the Amigo system, the catheter is navigated by a remote controller that mimics catheter handles, reducing the time needed for physicians to learn and feel comfortable using a robotic catheter system.

David Jenkins, President and CEO believes that the approval of Amigo is not only beneficial for Catheter Robotics, but also for the advancement of robotics in the electrophysiology field. "We have a product that will benefit physicians and hospitals and we are excited to have it available to the marketplace. Amigo meets the performance expectations of physicians while meeting the cost expectations of hospitals, and creates a solution to the unmet needs of current robotic systems. Catheter Robotics continues to be dedicated to meeting the needs of patients, physicians and hospitals within the electrophysiology lab."

Amigo was evaluated at 13 centers worldwide which enrolled more than 200 patients. Jennifer Englund, Vice President of Clinical and Regulatory Affairs feels very positive about the results of the clinical trial. "The clinical trial was a great success and resulted in data that exceeded our safety and efficacy objectives. The trial data demonstrated effective catheter navigation with Amigo (sufficient tissue contact, ability to navigate the catheter to multiple pre-determined points in the right heart, and ease of use) and a strong safety profile (no major complications related to Amigo). We are truly excited to have 510(k) clearance of Amigo by the FDA, which allows us to market the device in the US."

 
Amigo™ Receives CE Mark

Catheter Robotics is pleased to announce that Amigo received the CE Mark in March 2010.

Amigo is intended to facilitate manipulation, positioning and control of mapping catheters for collecting electrophysiological data in the right heart (right atrium and ventricle). Amigo is indicated for use with the following catheters:

 

Biosense-Webster EZ SteerCS Bi-Directional catheter (Biosense-Webster, Diamond Bar, CA)

 
Catheter Robotics, Inc. Completes Acquisition of VIVO Product Line; Changes Name to Catheter Precision, Inc.

Mount Olive, NJ – May 24, 2016 – Catheter Robotics, Inc. (CRI) has announced that it has completed the acquisition of its new product line to be named VIVO. VIVO is a computerized three dimensional cardiac mapping system showing electrical activation of the ventricles of the heart. VIVO stands for View Into Ventricular Onset.

In conjunction with the introduction of VIVO and moving into multiple product lines, CRI has chosen to change its name from Catheter Robotics, Inc. to Catheter Precision, Inc. Both the Amigo and VIVO products are oriented towards providing precision for catheter procedures in cardiac electrophysiology including both atrial fibrillation and ventricular arrhythmias.

Missiaen Huck, Director of Marketing of CRI commented, "With the acquisition of VIVO we are addressing an unmet need in cardiac EP. For the last ten to fifteen years new catheter technologies have been focused on treating atrial fibrillation. Our new VIVO technology is for catheter treatment of ventricular arrhythmias, a disease treated generally by an expensive implantable defibrillator or by the lengthy catheter ablation procedures in a small number of centers. Our technology should allow the catheter procedures to be accepted and used on a general basis, even in the community hospitals. As such this provides a game changer to fuel a much larger marketplace of the electrical malfunctions of the ventricles."

Vivo allows the physician to accurately pinpoint the origin of a ventricular arrhythmia. The company intends to seek FDA approval later this year.

 

 

What Doctors Are Saying About Amigo™

Read what some experienced physicians have to say of Amigo.

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The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation has not been established.
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