Hengsheng Medical Announces Global Launch of Hengyan® Coronary Self-Perfusing Drug-Coated Balloon Catheter

Hengsheng Medical Unveils the World’s First Self-Perfusing Hengyan Coronary Drug-Coated Balloon Dilation Catheter (hereinafter referred to as “Hengyan”^®“Self-Perfusing Drug-Coated Balloon”), this product was independently innovated and developed by Hengyi Medical, a subsidiary of the Hengsheng Medical Group, and officially received its registration certificate from the National Medical Products Administration on March 13.

Hengyan, which has been approved for market launch^®The self-perfusing drug-coated balloon is indicated for the treatment of in-stent restenosis and bifurcation lesions in coronary arteries. Its unique self-perfusing capability ensures that blood flow is not obstructed during balloon inflation, allowing for prolonged vessel wall apposition. This facilitates more complete drug elution and enhances therapeutic efficacy. The market launch of this product signifies that drug-coated balloon dilation time is no longer limited to 60 seconds, and it heralds a renewed expansion of the clinical application scenarios and perspectives for domestically produced drug-coated balloon catheters in China.

1. Common Sayings^®The self-perfusing drug-coated balloon employs a unique perforation technique that connects the guidewire lumen to the external environment, thereby enabling self-perfusion. The balloon retains an overall rapid-exchange dual-lumen design, facilitating proficient manipulation by the operator.

2. Safer and More Comfortable: During balloon dilation, after the guidewire is withdrawn to the proximal MARK point, blood flows through the guidewire lumen to the distal end without obstructing blood flow, ensuring greater safety and comfort for the patient.

3. More Effective: Unlike other drug-coated balloons on the market that obstruct blood flow during expansion, Hengyan^®During the expansion of the perfusion drug-coated balloon, 15% of blood flow is maintained distally, which allows for prolonged dilation time, reduces elastic recoil of the vessel, enhances the transfer rate of paclitaxel, ensures more complete drug release, and improves therapeutic efficacy.

Hengyan^®The pre-market clinical trial of the drug-coated balloon was led by Peking University First Hospital, with Professor Huo Yong serving as the principal investigator (PI).

①In-Stent RestenosisThe control group was B. Braun's SeQuent^®Please, the primary clinical endpoint is late lumen loss within the target lesion segment at 9 months.

In both the FAS and PPS datasets, the upper limit of the 95% confidence interval (CI) for the mean difference in late lumen loss within the target lesion segment at 9 months between the two groups was below the prespecified non-inferiority margin of 0.195 mm, thereby establishing non-inferiority. Furthermore, throughout the clinical trial, the mean dilation time for the Hengyan self-perfusing drug-coated balloon was longer than that of the control group, as shown in the figure below:

②Bifurcation LesionThe control group used the Qingzhou stent from Yinyi, with the primary clinical endpoint being the percentage of diameter stenosis in the target lesion branch vessel at 9 months post-procedure.

Conclusion: In both the FAS and PPS datasets, the upper limit of the 95% confidence interval for the mean difference in the percentage diameter stenosis of the target lesion branch vessels at 9 months was less than the prespecified non-inferiority margin of 7%, thereby establishing non-inferiority.

(1) Compared with other spraying methods, ultrasonic spraying technology enables more precise drug loading, a more uniform coating, and controllable release.

(2) No excipients, avoiding allergic reactions, vascular inflammation, and other adverse events caused by excipients (such as iopromide, iohexol, etc.).

1. The balloon is made of new PEBAX material, offering higher compliance and superior deliverability.

2. The unique folding process results in a smaller outer diameter of the balloon, enhancing its crossability.

3. The catheter is coated with a hydrophilic coating, and the smooth catheter surface facilitates easier passage through lesions.

4. The balloon delivery system utilizes a next-generation rapid-exchange balloon catheter with a spiral-cut hypotube design and a reinforced transition section to optimize pushability transmission, enabling faster balloon delivery and minimizing drug concentration loss caused by blood washout.

Hengyan^®The launch of the drug-coated balloon adds a new therapeutic product to Hengsheng Medical’s “Diagnosis + Treatment” portfolio in the field of cardiovascular intervention. With this milestone, all three of Hengsheng Medical’s core product lines are now commercially available, further elevating the company’s market competitiveness.

A high-quality drug-coated balloon catheter must meet three criteria: first, the drug should adhere well to the balloon surface during delivery; second, it should enable rapid drug transfer within a short period; and third, the drug should be released sustainably within the blood vessel. Hengyan^®As a new generation of domestically produced drug-coated balloon dilation catheters, the self-perfusing drug-coated balloon not only possesses all the features of conventional drug-coated balloons but also features a unique self-perfusion function that prolongs wall apposition time. It is anticipated that, following market launch, it will be applied more safely and effectively in both general and complex lesions, thereby delivering greater clinical benefits to a broader population of patients with cardiovascular disease.

Hengsheng Medical Group is a high-end medical device conglomerate dedicated to innovation. With 28 years of deep industry engagement, the company has consistently adhered to independent innovation and focused on the “diagnosis + treatment” field of cardiovascular intervention. Headquartered in Beijing, it also maintains R&D centers in Chengdu, Hangzhou, and Boston, USA. The company currently offers 16 products, holds 14 NMPA registration certificates and 6 CE certificates, and its stents were selected for the centralized procurement program at the highest bid price.

Hengsheng's product line is shown in the figure below: