CIRCA Scientific's PeriCross™ Kit Receives FDA Approval
CIRCA Scientific's Revolutionary Epicardial Access Kit
CIRCA Scientific has achieved a significant milestone with the FDA granting 510(k) clearance for the PeriCross™ Epicardial Access Kit. This innovative system is designed to facilitate a more controlled and efficient access to the pericardial space via a subxiphoid approach, providing a vital tool for healthcare professionals in the cardiovascular field.
Overview of the PeriCross™ Epicardial Access Kit
The PeriCross system employs a unique tine-based retraction mechanism in conjunction with a 21-gauge micro-puncture needle. This design promotes effective separation between the pericardium and myocardium before the needle is advanced, marking a substantial advancement for physicians undertaking epicardial procedures. The product’s purpose is to enhance control, support consistency, and streamline the procedural workflow, thus making it an invaluable asset in cardiac interventions.
Clinical Outcome Highlights
Recent data from the EASY-R trial, which involved 21 patients, reported a remarkable 100% access success rate. The average time required for access was just 3.5 minutes, with low fluoroscopy duration and minimal contrast agent usage. Such efficiency is crucial in time-sensitive cardiac procedures, leading to improved overall patient outcomes.
Expert Testimonials on the PeriCross System
Dr. Petr Neuzil, a leader in cardiac arrhythmia services, praised the PeriCross system, stating, "It addresses one of the most challenging aspects of epicardial procedures with its elegant design. Our clinical experience reflects its reliability and efficiency across various patient anatomies." Additionally, Dr. Vivek Reddy highlighted the simplicity and intuitive nature of the device, noting how it integrates seamlessly into existing workflows, ultimately reducing the variability that often plagues epicardial access.
Upcoming Presentations and Availability
Further data from the clinical trial will be shared at a major upcoming event, the Heart Rhythm Society (HRS) 2025 Annual Meeting. This platform will allow for greater visibility into the device's capabilities and the promising results it has delivered in preliminary studies. Following its FDA clearance, the PeriCross kit is set to launch in the U.S. market within the next few months, with international availability anticipated by 2026.
Lee Geist, President and CEO of CIRCA Scientific, expressed his enthusiasm about this breakthrough: "The clearance of PeriCross is a critical step in our mission to equip physicians with advanced tools that facilitate complex cardiac procedures. This product significantly enhances our portfolio and aligns with our CardioCentric™ vision focused on procedural innovations that benefit patients and healthcare practitioners alike."
About CIRCA Scientific
CIRCA Scientific is devoted to empowering healthcare professionals with pioneering technologies that improve access and control in complex medical interventions. With a focus on a CardioCentric™ approach, the company strives to boost procedural success rates and enhance patient care. For more details about CIRCA Scientific and its offerings, visit their official website.
Frequently Asked Questions
What is the PeriCross™ Epicardial Access Kit?
The PeriCross kit is a device designed to assist healthcare providers in accessing the pericardial space safely and efficiently through a subxiphoid approach.
How does the PeriCross system work?
It utilizes a tine-based retraction mechanism along with a micro-puncture needle to create separation between the heart tissue layers, facilitating easier access.
What are the results from the EASY-R trial?
Preliminary findings showcased a 100% success rate for access with an average access time of 3.5 minutes and low fluoroscopy time, indicating its effectiveness.
When will the PeriCross kit be available?
The kit is expected to launch in the U.S. market soon, with plans for expansion to international markets in the upcoming years.
What is CIRCA Scientific's mission?
CIRCA Scientific aims to deliver innovative solutions for complex cardiac procedures, enhancing patient care and procedural success through advanced technologies.
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