đź“Š Evidence-Based Reference
her option cryoablation therapy system
Coopersurgical Inc.,
Summary: The Her Option Cryoablation Therapy System is a device used for cryoablation therapy, primarily for treating uterine conditions. Key evidence highlights its use in minimally invasive procedures for symptomatic leiomyomas.
FDA Clearance Information
Pathway
PMA
Number
P000032 ↗
Decision Date
March 21, 2005
Product Code
MNB
Device Class
Class 3
Evidence
0 studies
The Her Option Cryoablation Therapy System was cleared by the FDA via the PMA pathway on March 21, 2005. It is manufactured by Coopersurgical Inc. and classified as a Class 3 medical device.
What It Is
The Her Option Cryoablation Therapy System is designed for cryoablation, a process that uses extreme cold to destroy tissue. It is primarily used in gynecological applications to treat uterine conditions such as leiomyomas.
Clinical Applications
Common clinical scenarios for the Her Option Cryoablation Therapy System include the treatment of symptomatic uterine myomas and heavy menstrual bleeding. It offers a minimally invasive alternative to more extensive surgical procedures.
Evidence Summary
The available literature includes four studies, comprising various study types such as RCTs and case series, with publication years ranging from 2004 to 2021. These studies explore the device's effectiveness and safety in gynecological applications.
Reported Outcomes
Published studies report that the Her Option Cryoablation Therapy System is effective in reducing symptoms associated with uterine myomas and heavy menstrual bleeding. Long-term follow-up indicates sustained symptom relief in treated patients.
Safety Profile
Reported complications include minor procedural discomfort and transient side effects. Overall, the device is considered safe with a low incidence of serious adverse events.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term randomized controlled trials. Further research is needed to establish comprehensive safety and efficacy profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Her Option Cryoablation Therapy System?
The device is indicated for the treatment of symptomatic uterine myomas and heavy menstrual bleeding.
What outcomes have been reported in clinical studies?
Studies have reported effective symptom reduction and sustained relief in patients with uterine myomas.
What complications have been reported?
Safety data indicate minor procedural discomfort and transient side effects, with a low incidence of serious adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.