# Nordica Cryoablation System
Cryogenic Ablation System (Nordica)It is an innovative medical device, mainly used forTreatment of Atrial Fibrillation（AF），ThroughThe cryoballoon is placed against the pulmonary vein ostium, using low temperatures to deactivate the tissue, thereby isolating electrical signals., helping the heart restore its normal heartbeat.
Nordica Cryoablation SystemIn China, the mainstream cryoablation products are currently launched by Medtronic.Arctic Front Series, This product adopts a double-layer balloon and high-pressure design and has been widely used in clinical settings, but this series of productsThere are still some shortcomings.：- The double-layer design reduces the compliance of the balloon.Which may cause the balloon to shift during the inflation ablation process,Leading to incomplete pulmonary vein isolation (PVI);
- The design of the high-pressure balloon poses a higher risk of refrigerant leakage in the event of balloon rupture.
And Nordica Cryogenic Ablation SystemImproved the design of the cryoballoon and circular mapping catheter, with the balloon adopting a single-layer polyurethane design and being size-adjustable., and the balloon maintains a low and constant pressure during the freezing process.- Nordica balloon is designed with a single layer.Compared with the double-layer balloon, it has better compliance, which helps to achieve transmural PVI and reduce the probability of segmental ablation and adjacent tissue damage.
- Balloon's Internal Pressure Maintenance3 -5 psig, and highly leak-proof, the designCan avoid displacement caused by a sudden increase in balloon pressure during ablation, and reduce the incidence of pulmonary vein non-isolation events due to insufficient contact.
In addition, the compliant balloon design of NordicaMore Conforming to the Anatomy of the Pulmonary Veins, without the need to apply additional thrust, the pulmonary vein occlusion can be easily completed.# Latest Experimental DataIn June 2024, the animal experimental results of the Nordica system were published for the first time.- A total of 12 upper pulmonary vein PVI ablations were completed in 6 dogs, among which11 PV Treatments BeforeComplete occlusion can be achieved (4 points).A Total of 37 Cryoablation Procedures Completed, among whichLeft Upper Pulmonary Vein LSPV19 Times, Left Upper Pulmonary Vein RSPV18 Times(For details, see Table 1).
- Among them, 4 dogs canWithin 5 ablationsCompletion of Bilateral Pulmonary Vein Isolation。
- 86.4% of the timeThe cryoablation occlusion score is greater than 3 points,56.7% of the timeCryoablation can achieve complete occlusion (4 points)。50%(6/12)The pulmonary vein achieves "Single Shot",The average isolation time TTI was 26.2±10.0 s.(TTI less than 60 seconds is a strong factor in predicting durable PVI in cryoablation).
- All pulmonary veins were successfully isolated immediately.(Bidirectional conduction block, Fig. 2a-c) During the secondary electrophysiological examination 4 weeks later, all pulmonary veinsCan maintain bidirectional conduction block。
Table 1: Cryoablation Data
Surgery-related Complications and Adverse Events:All dogs survived to the 4th week and successfully completed the second electrophysiological examination. During the postoperative period and follow-upNo major adverse events or complications such as phrenic nerve paralysis, cardiac tamponade, or atrial-esophageal fistula occurred.。Average Diameter Change of Pulmonary Veins (n = 12) Immediately After Cryoablation1.09±1.28 mm(7.45%), Secondary Electrophysiological Examination2.00±1.90 mm(13.00%), without significant pulmonary vein stenosis (Fig. 2d-f).
Figure 2: Intraoperative Image Data Record
The ablation area on the endocardial surface of the pulmonary vein shows tissue discoloration, with the width of the ablation lesion.10-15mm, Ablation injury can be seen on the outer membrane surface,The indication caused transmural damage. No other device-related injuries were found.。Figure 3. Macroscopic and Microscopic Changes After Cryoablation of the Pulmonary Vein
Left image: The ablation site shows a ring shape with endocardial whitening (within the dashed line); Right image: Transmural myocardium at the ablation site disappears (bracket), replaced by reactive fibrovascular tissue (asterisk), with minimal neointima formation (arrow); Upper image, GET staining; Lower image, H&E staining.This animal experiment successfully demonstrated the safety and efficacy of the Nordica Cryoablation System in the treatment of atrial fibrillation.：
# Product Market AnalysisAgainst the backdrop of a yearly increase in the number of atrial fibrillation (AF) patients in China, a total of 81,900 AF ablation procedures were performed domestically in 2020, of which 9,800 were cryoablation and 72,100 were radiofrequency ablation.It is estimated that the number of atrial fibrillation ablation procedures in China will reach 814,400 by 2030., with a compound annual growth rate of 25.8% from 2020 to 2030, whereThe Compound Annual Growth Rate (CAGR) of AF Cryoablation from 2020 to 2030 is 36.9%。
According to Frost & Sullivan data analysis,The Global Market Size of Cryoablation Catheters for Atrial Fibrillation is Expected to Reach 7.7 Billion USD by 2030(approximately RMB 54.6 billion). In China, the market size of cryoablation catheters for atrial fibrillation increased from RMB 48.4 million in 2016 to RMB 250 million in 2020, with a compound annual growth rate of 51.5%.Driven by the increasing prevalence of atrial fibrillation and the growing penetration of cryoablation therapy，The Chinese Market Size for AF Cryoablation Catheters is Expected to Reach RMB 5.1 Billion by 2030。Globally,Medtronic was the first manufacturer to launch a cryoablation device for atrial fibrillation., launched the Arctic Front cryoballoon atrial fibrillation ablation system in 2010,Has been in a monopolistic position for over 10 years., the product has currently been launched in China.In June 2021, the FDA expanded its approval of Medtronic's Arctic Front series of cardiac cryoablation catheters for the treatment of recurrent symptomatic paroxysmal atrial fibrillation (AFib). In February 2022, Medtronic received FDA approval in the United States for the Freezor and Freezor Xtra cardiac cryoablation catheters.AndThe approval and market launch of Boston Scientific's POLARx™ FIT Cryoablation Balloon Catheter have ended Medtronic's monopoly.In April 2023, Boston Scientific announced that its POLARx™ FIT cryoballoon catheter had received CE approval. It was specifically noted that the catheter isThe only cryoablation system on the market that provides dual-diameter balloon sizes in a single catheter.In August 2023, the POLARx™ Cryoablation System received FDA approval in the United States. The "race" between the two giants may also hint at a new phase for the entire cardiovascular ablation market.In China's local enterprises,Kangfeng Bio, MicroPort EP, Antech, Shenwei MedicalCompanies are also entering the atrial fibrillation cryoablation market.August 2023,Shanghai MicroPort EPIndependently DevelopedIceMagic® Balloon Cryoablation Catheter and IceMagic® Cryoablation SystemApproved by NMPA for marketing, becomingThe First Chinese-produced Cryoablation Product Approved for Atrial Fibrillation Treatment, filling the gap in China.December 4, 2023Kangfeng BioCryogenic Ablation Equipment and Balloon Cryoablation Catheter of the Cardiac Cryoablation System Approved for Marketing by NMPA. On December 11, the Steerable Guide Catheter and Single-Use Intracardiac Mapping Catheter of the Cardiac Cryoablation System, produced by Kangfeng Biotech, were approved for marketing by NMPA.It is worth noting that, in addition to facing competition from atrial fibrillation radiofrequency ablation technology, atrial fibrillation cryoablation technology also faces the emergence of a newer generation of atrial fibrillation ablation technology——Competition in Atrial Fibrillation Pulse Field Ablation (PFA) Technology。Pulse Field Ablation for Atrial Fibrillation Offers Higher Precision and Fewer Complications, Considered the Future Direction of Atrial Fibrillation Ablation TechnologyFrom this perspective, the future development of the atrial fibrillation cryoablation industry will face increasing competitive pressure.
According to Frost & Sullivan analysis,China's Atrial Fibrillation Pulsed Field Ablation Market Size is Expected to Reach 1.287 Billion Yuan by 2025`, and maintain rapid growth,`Expected to reach 16.315 billion yuan by 2032, with a CAGR of 43.73%. The proportion of China's atrial fibrillation pulsed field ablation device market size in China's overall cardiac electrophysiology device market size is also expected to continue rising.Increased from 8.18% in 2025 to38.87% in 2032。At this stage, pulsed field ablation (PFA) has made significant progress in the treatment of atrial fibrillation, with multiple products already approved. PFA has rapidly become a new technology for treating atrial fibrillation, but it is undeniable that,At present, the safety and effectiveness of PFA still need to be confirmed by larger-scale clinical studies, and the optimal ablation energy parameter settings and workflow standards remain to be determined.。Although preclinical studies strongly suggest that the PFA ablation strategy offers higher safety for adjacent esophagus, phrenic nerve, and vascular tissue. However, as more procedures are performed and more data is released,Whether postoperative complications are really as optimistic as currently reported, and the long-term effectiveness of PFA, The potential issues of this series of new technologies still require strong answers from relevant high-quality research.Therefore,Cryogenic ablation is likely to remain one of the mainstream technologies for atrial fibrillation ablation in the foreseeable future.Synaptic Medical's new cryoablation system, Nordica, still has certain advantages.
# Company Profile
Synaptic Medical is a company focused onA US-owned enterprise in the field of cardiac electrophysiology, headquartered in Minnesota, USA, in 2007Beijing Establishes Wholly-Owned Subsidiary——Synaptic Medical Technology (Beijing) Co., Ltd., with Synaptic Medical's R&D and manufacturing center in China, currently has more than ten product lines for diagnosing and treating arrhythmia diseases. Meanwhile, multiple products have obtained registration certificates from the United States, the European Union, and Japan.
Synaptic Medical is committed to becoming a provider of comprehensive solutions for cardiac electrophysiology, continuously leading the industry in technological innovation.The existing products cover three major categories of atrial septal puncture instruments, diagnostic instruments, and therapeutic instruments, totaling dozens of types., building a complete business system covering R&D, manufacturing, and sales. Among these, the atrial septal puncture device has entered nearly 2000 hospitals in China, the United States, Japan, Europe, and other regions due to its performance advantages.
Synaptic Medical, driven by its U.S. Innovation and R&D Center,Actively promoting revolutionary innovative projects such as the 3D mapping system (Meridian), intracardiac echocardiography (ICE) diagnostic catheters and equipment (enVision)., continuously improving the safety and effectiveness of atrial fibrillation procedures, enhancing the clinical operation experience for operators, and benefiting a large number of cardiovascular disease patients.
