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  1. Recently-Approved Devices

QDOT MICRO System – P210027

Nine labeled components of the QDOT MICRO System

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the [Summary of Safety and Effectiveness Data (SSED) / Summary of Safety and Probable Benefit (SSPB)] and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: QDOT MICRO System
PMA Applicant: Biosense Webster, Inc
Address: 31 Technology Drive, Suite 200
Irvine, CA, USA 92618
Approval Date: November 23, 2022
Approval Letter:  Approval Order

What is it?

The QDOT MICRO System includes a thin, flexible wire (catheter), a radiofrequency (RF) generator, a pump, and connection cables. The catheter takes energy from the RF generator and delivers it to a specific location inside the heart. The catheter can also be used to record electrical signals in the heart and stimulate the heart muscle for diagnostic purposes. The pump provides fluid to cool the catheter tip.

These components are used for a procedure called catheter ablation to treat people who have both abnormal, irregular, and fast heartbeats called paroxysmal atrial fibrillation and type 1 (or typical) atrial flutter, which is when the heart beats too fast, but in a regular rhythm. These two conditions often happen in the same person.

How does it work?

A doctor puts the catheter into a vein in the groin and moves it through the blood vessels up to the heart. The catheter is placed at different locations in the heart that are causing the abnormal heartbeat. The tip of the catheter delivers heat energy from the generator to these areas to destroy them and correct the heartbeat. The catheter is removed after treatment.

When is it used?

The catheter and other system parts are indicated for treating two types of abnormal heartbeat which often happen to the same person: drug refractory recurrent symptomatic paroxysmal atrial fibrillation, which is an irregular heartbeat that causes noticeable symptoms, does not respond to medications, happens more than once but each episode stops within 7 days, and type 1 atrial flutter.

What will it accomplish?

In a clinical study, doctors used this system to treat 175 people with paroxysmal atrial fibrillation with or without co-existing atrial flutter. The participants were followed for 12 months after the treatment. Abnormal heartbeats did not return within one year for 76% of people who were treated.

When should it not be used?

The device should not be used in people who:

  • Had a heart surgery where an incision was made into at least one of the four heart chambers within the last twelve weeks.
  • Have tumors (myxoma) or clots (thrombus) inside the heart.
  • Have artificial heart valves.
  • Have infections in their bloodstream (active systemic infections).

The device should be used in limited ways for people who:

  • Have some types of heart patches (repairs).
  • Had their aortic valve replaced.

Additional information (including warnings, precautions, and adverse events):

 

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