Boston Scientific's AGENT Drug-Coated Balloon Receives FDA Approval for Coronary In-Stent Restenosis Treatment

# About Agent DCB

Agent DCB is a product that adoptsTransPax Coating TechnologyDrug-coated balloon for the treatment ofISR and Coronary Small Vessel Disease Patients Previously Untreated. ThroughTransPax™ Coating Technology, capable of targeting coronary artery lesion sitesProviding Targeted Therapeutic Doses of Antiproliferative PaclitaxelIt can also minimize particles while maintaining excellent delivery capacity.

▲Source: Company's official website

Agent DCB The drug-coated balloon adopts advanced balloon technology and hasUltra-low tip profile, ensuring ease of navigation through complex and distal lesions during cardiovascular interventional procedures.

The low-profile design of the balloon supports simultaneous use within the catheter.The dual-segment inner shaft structure enhances trackability in tortuous distal anatomy., while the low profile and flexible distal design optimize the balloon's ability to cross narrow sections and reduce the risk of slippage.

▲Source: Company's official website

In addition, the surface of the balloonLubricious Coating (Z Glide™)Further improved traceability, andPlatinum Marker BandThis enhances visibility during the operation process, making the balloon position clearer and improving the precision and safety of the surgery.

# Clinical Trial Results

At the 2022 TCT conference, Boston Scientific announced the IDE clinical research data for the Agent DCB.AGENT IDE is a key randomized trial designed to compare ISR patients.AgentPaclitaxel Coated Balloon (Agent DCB) and the safety and effectiveness of treatment with traditional balloon angioplasty。

A total of 480 patients with ISR who had previously undergone stent implantation treatment and had coronary artery obstruction were enrolled from 40 centers in the United States. After successful pre-dilation of the target lesion, the patients were randomly assigned at a ratio of 2:1 to receiveAgent DCB(n=321) or balloon angioplasty (BA, n=159) treatment.Primary EndpointTarget Lesion Failure at 1 Year(Composite endpoint consisting of obstruction recurrence, treatment-related heart attacks, or cardiac death)Incidence rate。

The results showed,The primary endpoint of target lesion failure (TLF) was reached at 12 months.。Agent DCB The target lesion failure rate in Group 1 was significantly lower than that in the BA group at 1 year.（17.9% vs. 28.7%, P=0.0063, ), suggestingAgent DCB Significantly superior to BA in reducing target lesion failure rate.

▲ Primary Endpoint Results (Source: Company Website)

▲Target Lesion Revascularization Rate and Target Vessel-Related Myocardial Infarction Rate（(Source: Company's official website)

▲Stent Thrombosis Results（(Source: Company's official website)

Drug-coated balloon angioplasty allows the medication to act on the inner wall of the blood vessel, providing better maintenance of vascular patency without leaving any foreign objects inside the vessel.Significant advantages in ISR, small vessels, and bifurcation lesions., the expansion of primary lesions has also been continuously explored and verified.

With the promotion of the "intervention without implant" concept in recent years, the usage of drug-coated balloons has grown rapidly. According to Frost & Sullivan's forecast data, after drug-coated balloons were first approved for the treatment of coronary artery disease in China, the usage increased significantly from 7,500 units in 2016 to 290,000 units in 2021.The market size is expected to further increase to 1,000,000 units by 2025 and reach 2,042,000 units by 2030.。

▲Originated fromFrost & Sullivan

#About Boston Scientific

Boston Scientific (NYSE: BSX) was founded in 1979 and is headquartered in Natick, Massachusetts, USA. It is a global leading medical technology company.

In 1997, Boston Scientific entered China, establishing branches and R&D centers in Beijing, Shanghai, and Guangzhou. The company's headquarters in China is located in Shanghai.Boston Scientific has more than 17,000 products and has been granted over 16,000 authorized patents worldwide.In May 1992, Boston Scientific successfully went public on the New York Stock Exchange.

On January 31, 2024, Boston Scientific announced its annual financial results for the 2023 fiscal year. The report showed that in this fiscal year, the company:Annual net sales were $14.24 billion (approximately 101.1 billion RMB), representing a year-over-year increase of 12.3%.; Net sales in the fourth quarter were $3.73 billion, representing a year-over-year increase of 14.9%;

By department, the companyBusiness is divided intoMedical Surgery and CardiovascularTwo Major Blocks, The growth rates of the two major businesses were similar: the former achieved an organic growth of 10% for the full year, with total net sales reaching $5.422 billion;The latter achieved 13% organic growth for the full year (with electrophysiology growing by 33% and the Watchman left atrial appendage closure device growing by 25%), with total net sales reaching $8.819 billion.。