Cardiac Surgery Cryoablation System

Recently, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) updated the public notice on the review results of applications for special review of innovative medical devices (2024 No. 5). This notice includes the cardiac surgery cryoablation system from Hejeya (Beijing) Medical Device Co., Ltd. However, detailed information about this product has not yet been released.

Since its inception, the company has comprehensively focused on minimally invasive oncology and cryomedicine. In addition to developing its core product, “Kangbo Knife,” Hejeya has been exploring new fields horizontally. These include the atrial fibrillation surgical cryoablation system and internal medicine ablation systems, focusing on the development of cardiac ablation products and building a cryogenic platform. 

“Atrial fibrillation is a highly prevalent condition among cardiovascular diseases. Currently, there are no particularly effective treatment methods. Cryoablation technology has shown very promising applications in treating atrial fibrillation according to various domestic and international studies. We have thus formulated some R&D plans for this,” explained Hejeya’s President, Luo Fuliang. “Additionally, cryolipolysis has been proven to be a very good technique abroad, and we foresee potential in this area as well. From a technical perspective, it doesn’t pose significant challenges for us, making it a potential future development direction.”

Cryoablation

Cryoablation is a process that uses extremely cold agents to freeze and destroy abnormal cells or diseased tissue. This technique is used to treat various cancers and arrhythmias. During cryoablation, a cryogenic agent such as liquid nitrogen, argon gas, nitrous oxide, or carbon dioxide is introduced into the ablation needle. This agent produces low temperatures at the treatment site, freezing the diseased tissue.

Atrial fibrillation (AF) cryoablation is a minimally invasive interventional procedure that belongs to the broader category of interventional cryotherapy techniques. It is one of the three major technological approaches for AF ablation. AF cryoablation combines cryoablation technology with catheter technology to rapidly freeze abnormal heart tissue. This process lowers the temperature of the target tissue quickly, destroying abnormal tissue cells and thereby achieving the treatment goal for atrial fibrillation. AF cryoablation is a novel technique for treating arrhythmias developed after the introduction of radiofrequency ablation for AF.

▲Basic Components of a Cryoablation System

Compared to traditional thermal ablation, cryoablation technology causes less trauma, is simple and convenient to operate, and has clear ablation boundaries that allow doctors to more easily determine the extent of ablation, significantly improving safety. Additionally, the postoperative complication rate is low, with no significant severe complications observed. Patients can recover in a short period after surgery, and compared to other technologies, cryoablation has relatively outstanding recovery effects. The procedure is less painful and can be performed under local anesthesia.

▲Radiofrequency

▲Ablation, Cryoablation

Cryoballoon catheter ablation is currently an innovative technology for the treatment of atrial fibrillation, offering excellent safety and effectiveness. It achieves its therapeutic effect by causing necrosis of target myocardial cells through low temperatures induced by cryogenic energy. By using cryoballoon ablation technology, the electrical signals from the pulmonary veins that interfere with the heart’s normal rhythm are blocked, thereby treating atrial fibrillation.

However, cryoablation also has its drawbacks. Compared to microwave ablation, cryoablation takes longer and is more expensive than thermal ablation equipment. The prevalence and accessibility of cryoablation equipment are also lower.

Market Overview

Atrial fibrillation (AF), also known as atrial flutter, is the most common cardiac arrhythmia disease. Chronic conditions such as hypertension and coronary heart disease can lead to AF. With increasing age and the prevalence of chronic diseases, the number of AF patients is rising, reaching approximately 20 million cases in China alone. AF not only reduces patients’ physical capacity and quality of life but also increases the risk of serious conditions like stroke and heart failure, posing a significant threat to human life. Treatment is necessary, and there is substantial market potential for cryoballoon catheter ablation in the AF market.

Currently in China’s AF ablation market, radiofrequency (RF) ablation dominates with a market share of 88% as of 2022, due to its mature technology and proven efficacy. RF ablation uses thermal effects to dehydrate and necrotize abnormal heart tissue to achieve therapeutic goals. However, RF ablation procedures can be painful for patients due to high temperatures. Cryoballoon catheter ablation, as a new technology for AF treatment, utilizes rapid freezing techniques, resulting in lower patient discomfort, shorter operation times, and fewer complications. This is exerting competitive pressure on the RF ablation market.

According to the New Horizons Industry Research Center’s “2023-2028 China AF Cryoballoon Catheter Ablation Market In-depth Research and Development Prospects Forecast Report,” cryoballoon catheter ablation accounted for only 7% of AF ablation procedures in China in 2016, but by 2022, this share had increased to 12%. It is projected to reach 25% by 2028. In 2022, there were 150,000 AF ablation procedures performed in China, with cryoballoon ablation procedures totaling 18,000. It is estimated that by 2028, the number of cryoballoon catheter ablation procedures for AF in China will approach 148,000.

Medtronic was the first global manufacturer to introduce cryoballoon ablation devices for atrial fibrillation (AF), launching the Arctic Front cryoballoon AF ablation system in 2010, which is currently marketed domestically in China. Medtronic holds a dominant position in China’s AF cryoballoon ablation market. Domestic enterprises such as Koncen Bioengineering, MicroPort EP, AtriCure, and CardioFocus are also expanding their presence in the AF cryoballoon ablation market.

In June 2021, the FDA expanded its approval for Medtronic’s Arctic Front series cryoballoon catheters for treating recurrent symptomatic paroxysmal atrial fibrillation (AFib).

In February 2022, Medtronic received FDA approval for its Freezor and Freezor Xtra cryoballoon catheters for heart cryoablation.

In August 2023, Shanghai MicroPort EP MedTech Co., Ltd. (688351.SH) obtained NMPA approval for its self-developed IceMagic® balloon cryoballoon catheter and IceMagic® cryoablation device, becoming the first domestically approved cryoballoon ablation products for AF treatment in China, filling a domestic gap.

In addition to competing with RF ablation technology for AF treatment, cryoballoon ablation faces competition from the next generation of AF ablation technologies — pulsed field ablation (PFA) for AF. PFA offers higher precision and lower complication rates, positioning it as a future direction for AF ablation technologies. Looking ahead, the AF cryoballoon ablation industry will face increasing competitive pressures due to these factors.