Medical Device Products

       

Unique Shape-changing cardiac catheter

This catheter is intended for use in special cardiac rhythm correction procedures called "electrophysiology mapping". the intent of such procedures is to acquire electrical signals from the inside of cardiac chambers in order to determine the site of origin of rhythm problems. Once the site is located, a procedure called "ablation" is applied to cure the heart rate problem.

This catheter, unlike most others, allows the physician to gather data from multiple locations in the heart chamber without re-positioning the catheter, thereby saving time during the procedure.

The catheter contains a unique metal alloy called Nitinol, that changes shape when heated. In use, the physician inserts the catheter into the patient artery or vein as a linear device. Once it is in place in the cardiac chamber, the catheter is activated, causing it to move into a predetermined shape. A variety of shapes may be achieved by building the catheter in a particular fashion.

The X-ray pictures below show the catheter in the left ventricle chamber of an experimental animal. 

This concept was pioneered by company called Zynergy Cardiovascular in cooperation with world-renowned electrophysiologists at the University of Alabama medical college in Birmingham, Alabama. 

Zynergy Cardiovascular, formerly located in Edison, NJ is now wholly owned by Pickard Systems. The patent for this catheter is available for sale.

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Below is an excerpt from the patent.

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Standard EP Diagnostic cardiac catheters

 Pickard Systems owns a number of FDA 510(k) Premarket notifications for the manufacture and sale of different styles of electrophysiology catheters in the United States. 

These 510(k) catheter registrations are available for sale.

A file showing the actual registrations from the FDA 510(k) database may be downloaded here. Zynergy 510(k) Registrations #1 & Zynergy 510(k) Registrations #2

 

Electrode Recording Catheters: The FDA 510(k) registration documents are available here.

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Temporary Pacing Electrode Catheters

The FDA 510(k) registration documents are available here.

   

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Transvenous Bipolar Pacing Electrode & Pressure Monitoring Catheters

The FDA 510(k) registration documents are available  here & here

    

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