The FDA approved the cryoSPHERE+ to temporarily block pain in adult patients by ablating peripheral nerves and ablate intercostal nerves of patients aged 12-21 years under direct observation
AtriCure launches cryoSPHERE+ probe in US. (Credit: Piron Guillaume on Unsplash)
AtriCure, a surgical treatments and therapies developer, has introduced the cryoSPHERE+ cryoablation probe for post-operative pain management.
The cryoSPHERE+ probe, a part of the cryoICE platform, uses new insulation technology to decrease freeze times by 25% compared to AtriCure’s cryoSHPERE device.
It has been built upon the established safety and efficacy of the cryoSPHERE device, which received US Food and Drug Administration (FDA) clearance in November 2018. As of now, cryoSPHERE has supported more than 60,000 procedures.
The FDA granted 510(k) approval to the cryoSPHERE+ to temporarily block pain in adult patients by ablating peripheral nerves. It is also approved for patients aged 12-21 years by ablation of intercostal nerves under direct observation.
The new technology in the cryoSPHERE+ reduces thermal loss by focusing energy at the ball tip. This expedites the time it takes to reach a therapeutic temperature, and permits freeze time reduction and operative time reduction, AtriCure said.
AtriCure CEO president Michael Carrel said: “cryoSPHERE+ is a meaningful innovation that I believe will improve patient care, enhance outcomes, and enable physicians to perform procedures with greater ease and confidence.
“Since the launch of our pain management franchise over five years ago, we’ve seen a significant impact on patient’s lives, and with this launch, we look forward to serving even more people in the future.”
The cryoICE platform technology prevents nerves from sending pain signals for several months using a novel freezing technique.
According to the US-based surgical treatments and therapies developer, cryoSPHERE can be offered as Cryo Nerve Block therapy under a multimodal pain management strategy.
cryoSPHERE+ probe is anticipated to be fully launched by the end of Q2 in the US, where it is currently undergoing an extended limited launch period.
AtriCure develops treatments for atrial fibrillation (AFib) and related conditions. Its Isolator Synergy Ablation System received FDA approval for the treatment of persistent Afib.
Other products include AtriClip Left Atrial Appendage Exclusion System and Hybrid AF Therapy.