CIRCA SCIENTIFIC HAS RECEIVED FDA CLEARANCE FOR A NEW ESOPHAGEAL TEMPERATURE PROBE VISIBLE ON 3D HEART MAPPING SYSTEMS

0

ENGLEWOOD, Colo., March 3, 2022 /PRNewswire/ — CIRCA Scientific, Inc. today announced that its S-CATH™ M Esophageal Temperature Probe is now cleared for sale in United States. The new S-CATH M probe can be visualized on 3D cardiac mapping systems, which can help physicians reduce their reliance on fluoroscopy. It is the only commercially available multi-sensor esophageal temperature probe that provides high-density edge-to-edge coverage of the esophagus and is visible on 3D cardiac mapping systems.

Esophageal temperature probes can be used to alert physicians to critical changes in esophageal temperature that may occur during cardiac ablation procedures performed in the operating room (OR) or electrophysiology (EP) laboratory. However, many physicians currently rely on fluoroscopy to place, position, and reposition their esophageal temperature probe during a procedure. The use of fluoroscopy requires physicians and laboratory personnel to wear protective lead aprons to protect against radiation exposure.

The new S-CATH M has four electrodes that are placed on the centerline of the probe, allowing it to be placed, positioned and viewed on 3D mapping without relying solely on fluoroscopy.1 Additionally, S-CATH M features a proprietary micro-electrode design that limits the amount of exposed metal to what is absolutely necessary to be detected on 3D cardiac mapping systems, minimizing the possibilities for radio frequency (RF) interaction. . Research has shown that esophageal temperature probes with fully exposed metal electrodes can be inadvertently heated when used near the RF field.2-4

“We designed S-CATH M to support physicians’ efforts to minimize the amount of radiation their patients and staff are exposed to during their procedures without compromising the features that set our product portfolio apart,” said Lee Geist, President and CEO of CIRCA Scientific. “CIRCA Scientific is proud to join a growing community of medical device manufacturers responding to the demand for technology to reduce the use of fluoroscopy in OR and EP laboratories.”

About CIRCA Scientific
For the past 10 years, CIRCA Scientific has been the world leader in advanced esophageal temperature monitoring solutions. CIRCA’s esophageal temperature monitoring systems provide physicians with fast and reliable data to help them avoid excessive heating/cooling of the esophagus during therapeutic procedures performed in the OR or EP laboratory. For more information, visit www.circascientific.com and join us on Twitter and LinkedIn.

Media Contact: [email protected]

CS-PR001-0322 © CIRCA Scientific, Inc., 2022. All rights reserved. S-CATH, CIRCA Scientific and the CIRCA Scientific logo are trademarks of CIRCA Scientific, Inc. US Patents 9,155,476 B2 and 9,668,655. Other US and foreign patents pending. CAUTION: US law restricts this device to sale by or on the order of a physician. Before use, consult the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

1

Always ensure that you have a source of primary and secondary imaging and maintain the ability to verify probe placement with fluoroscopy if necessary.

2

Perez, JJ, et al. “Electrical and thermal effects of esophageal temperature probes on radiofrequency catheter ablation of atrial fibrillation: results from a computer modeling study.” Journal of Cardiovascular Electrophysiology (2015): 556-564.

3

Muller, P., et al. “Higher Incidence of Esophageal Injury After Atrial Fibrillation Ablation Related to Use of Esophageal Temperature Probes.” Heartbeat (2015): 1464-1469.

4

Halbfass, P., et al. “Incidence of asymptomatic esophageal lesions after ablation of atrial fibrillation using an esophageal temperature probe with isolated thermocouples: a controlled comparative study.” Europace (2017): 385-391.

SOURCE CIRCA Scientific, Inc.

Share.

About Author

Comments are closed.