G Vascular Subsidiary of Janssen Medical Announces FDA Approval of Chocolate Touch Drug-Coated Chocolate Balloon for Femoropopliteal Artery Disease

Recently, Vascular Interventional Sciences announced that its independently developed “Chocolate Touch Paclitaxel-Coated Chocolate Balloon” has recently received approval from the U.S. Food and Drug Administration (FDA) for marketing, for the treatment of stenotic and occlusive lesions in the femoropopliteal arteries. This is the first paclitaxel-coated chocolate balloon approved by the FDA.

Figure: Chocolate Touch Drug-Coated Balloon

In September last year, the National Medical Products Administration’s Center for Medical Device Evaluation (CMDE) approved the product for entry into the special review process (the “green channel” for innovative medical devices). The product was recognized as a “domestic first,” with its core technology and mechanism of action representing a fundamental departure from current drug-coated balloon (DCB) therapies, thereby offering significant clinical value. The CMDE has encouraged the product’s rapid market launch to help benefit patients in China.

Drug-Coated Balloons (DCBs) have gradually become a standard treatment for peripheral vascular disease due to their ability to deliver medication to the lesion site. However, similar to Plain Old Balloon Angioplasty (POBA), DCBs cannot completely overcome elastic recoil of the lesion. Balloon dilation can easily cause injury to the vascular intima, leading to arterial dissection and thereby compromising both short- and long-term patency.

The so-called chocolate balloon employs a specialized manufacturing process to create a chocolate-like undulating structure on its surface. This design provides a cushioning effect during dilation, thereby reducing damage to the vascular intima. However, currently available chocolate balloons are still unable to deliver drugs to the lesion site.

Chocolate Touch, on the other hand, is atDrug-Coated BalloonandTraditional Chocolate BalloonA major upgrade on this foundation: integrating the ideal luminal preparation of the chocolate balloon platform with the coating and attachment of the anti-proliferative drug paclitaxel. This breakthrough technology provides safer and more effective treatment for patients with peripheral vascular disease, achieving long-term vessel patency, fewer complications, and better prognostic outcomes.

The Chocolate Touch™ drug-coated balloon is expected to have significant clinical application value:

● Excellent Safety: Significantly Reduces Vascular Injury

● Optimized Therapeutic Efficacy: Efficient delivery and drug reloading ensure therapeutic outcomes and reduce the need for bailout stenting.

● Streamlined Surgical Procedure: One-stop treatment to reduce operative time

● Greater Cost-Effectiveness: Reduced Complications and Treatment Costs

Subsequently, Jianshi Medical will market its Chocolate Touch drug-coated chocolate balloon product in the U.S. market through its subsidiary, G Vascular.