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IceCure Medical has submitted a regulatory filing to China's National Medical Products Administration (NMPA) seeking the approval of its ProSense cryoablation system, which is designed for minimally invasive tumour destruction.
Intended for use in various surgical fields, the ProSense Cryoablation System is an expansion of IceCure Medical's current offerings in China.
The application to the NMPA builds upon the existing IceSense3 system, which already holds regulatory approval in the country.
It includes five different cryoprobes, each with different diameters, lengths, and shapes of ice balls.
The ProSense system is indicated for general surgery, including breast and lung tissues, as well as oncology, dermatology, urology, proctology, and gynaecology.
ProSense uses liquid nitrogen, which creates extensive lethal zones to destroy benign and malignant lesions.
With its transportable design and quick procedure times, the system claims to offer a ‘convenient’ option for office-based treatments, particularly for breast tumours.
Its single cryoprobe design claims to simplify the surgical process, reducing the potential for complications and shortening recovery times.
The system operates by inserting a cryoprobe into the tumour, guided by CT or ultrasound.
Liquid nitrogen then creates sub-zero temperatures, forming an ice ball that diminishes the tumour while sparing adjacent healthy tissue. The necrotic tissue is later absorbed by the body.
IceCure Medical CEO Eyal Shamir said: "China is potentially a very large market for cryoablation and we are moving forward with an expanded line of available products, as well as securing reimbursement so that IceCure can be ideally positioned to serve this important geography.”
IceCure’s ProSense Cryoablation System is already marketed and sold globally, with approvals in Europe, China, and the US for its cleared indications.
"IceCure submits application to China’s NMPA for cryoablation system approval" was originally created and published by Medical Device Network, a GlobalData owned brand.
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