Nuosheng Medical's Innovative Radiofrequency Transseptal Puncture Kit Receives NMPA Approval

Jun 12, 2024 19:53 CST Updated 19:53

Noya

Medical Device R&D and Manufacturer

Source of the article: Siyu MedTech, Noya

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On June 12, 2024, NMPA approvedHangzhou Noya Medtech Co., Ltd.Produced by "Disposable RF Transseptal Puncture Needle"Innovative Product Registration Application", the original text is as follows:

The single-use radiofrequency transseptal puncture needle, composed of a catheter with a radiofrequency puncture electrode tip and a control handle, is used in conjunction with the radiofrequency generator and steerable sheath produced by Hangzhou Noya Medtech Co., Ltd. It is designed for patients undergoing interventional cardiology procedures via transseptal puncture. The device facilitates access from the right atrium to the left atrium by performing a transseptal puncture, establishing a pathway between the two chambers to assist subsequent interventional devices in smoothly entering the left atrium.

Compared with traditional mechanical atrial septal puncture products, this product uses radiofrequency energy for puncture, requiring less mechanical force and offering more controllable puncture processes. The distal end is made of flexible, bendable material, which, when used with other adjustable instruments, allows for precise angle adjustments to reach target tissues while avoiding damage to non-target tissues. The fluid channel outlet is closer to the electrode tip, enabling more accurate and safer punctures. The handle is equipped with an energy control switch, which has a shorter response time compared to a foot pedal switch, improving the success rate and safety of atrial septal puncture procedures.

The pharmaceutical regulatory authorities will strengthen the post-marketing supervision of the aforementioned products to ensure patient safety in medical device usage.

# More Product Information

Clinical Needs for (RF) Transseptal Puncture

With the development of interventional treatments in fields such as cardiac electrophysiology and structural heart disease, the establishment of left-heart access has become particularly important in left-heart-related interventional procedures. The most critical step in establishing left-heart access is performing transseptal puncture, a technique that makes it possible for catheters and other devices to pass from the right atrium to the left atrium.

Atrial Septal Puncture Products Can Be Divided into Traditional Mechanical Puncture and New Energy Puncture by Product Type. Traditional mechanical puncture has the disadvantages of a long learning curve, potentially causing serious complications (such as cardiac tamponade and heart rupture), difficulty in accurately predicting the puncture site, and a relatively time-consuming process, placing extremely high demands on surgeons and restricting the development of some left-heart interventional procedures; new energy atrial septal puncture devices use brief and highly focused radiofrequency energy, allowing for reliable, controllable, and convenient puncture without the need for sharp mechanical needles to pass through the atrial septum, reducing the technical difficulty and complication rate of atrial septal puncture and shortening the learning curve.

Noya Medtech (RF) Atrial Septal Puncture Kit

Hangzhou Noya Medtech Co., Ltd.'s domestically首创, self-developed radiofrequency atrial septal puncture system uses blunt-tip electrodes to deliver radiofrequency energy for atrial septal puncture. When used with a steerable catheter, it achieves precise positioning, increases the success rate of puncture while reducing operation time; especially for complex atrial septums, such as tumorous atrial septum (thin, elastic) and fibrotic atrial septum (thickened), it demonstrates a higher success rate.

Product Composition and Design

Noya Medtech (RF) Atrial Septal Puncture Kit, composed of an atrial septal puncture system, a controllable catheter sheath, and an RF puncture device.

1. Using radiofrequency energy for atrial septal puncture, in conjunction with a steerable catheter, to achieve precise positioning.

2. The puncture needle has a smooth, blunt tip to avoid unintended tissue damage and the risk of generating particles when passing through the puncture sheath.

3. The distal end of the electrode is designed with a radiopaque marker for real-time monitoring of the distal position.

4. Contrast agent can be injected during the operation to accurately determine the puncture position.

5. The handle is equipped with an energy on/off switch, allowing for more convenient and safely controllable operation during surgery.

# AboutHangzhou Noya Medtech Co., Ltd.

Hangzhou Noya Medtech Co., Ltd., a subsidiary of D&H Group, was established in 2017. The company focuses on the development and commercialization of heart failure (HF) treatment products, including interatrial shunt systems.Noya's Self-developed ProductsNoYA™The radiofrequency interatrial shunt system is the world's first non-implantable product for interatrial shunting, ushering in a new era of non-implantable catheter-based treatments for heart disease and filling the gap in heart failure treatment, particularly for heart failure with preserved ejection fraction (HFpEF).

According to publicly available information, Hangzhou Noya Medtech Co., Ltd. was awarded the Excellent Enterprise Award in China's Innovation and Entrepreneurship Competition.As of the date of publication, 64 patent information entries were queried for the company, and Siyu has extracted some of the information as follows:

Siemens Healthineers

Johnson & Johnson MedTech

United Imaging HealthcareUnitedImaging

Editor-in-Chief | Zhao Qing Reviewed by | Yi He