Happy News | SUMPROMINENCE® Rapamycin-coated Coronary Drug Balloon Dilatation Catheter！

2025-06-03 14:12

Hangzhou Revita Medical Technology Co., Ltd., a subsidiary of Mednovo Group, has recently obtained China NMPA approval (Registration No.: 国械注准20253030999) for its independently developed SUMPROMINENCE® Rapamycin-Coated Coronary Drug Balloon Dilatation Catheter. This breakthrough provides interventional cardiologists with an additional treatment option, contributing to the advancement of "implant-free" solutions for coronary artery disease.

This marks the 38th medical device registration certificate awarded to Mednovo Group and represents another milestone in its cardiovascular portfolio. The approval of SUMPROMINENCE® further strengthens the Group’s portfolio of high-value medical consumables in cardiovascular interventions, reinforcing its core competitiveness in the field.

SUMPROMINENCE^® Rapamycin-coated Coronary Drug Balloon Dilatation Catheter

SUMPROMINENCE® rapamycin-coated coronary drug balloon dilatation catheter is a rapid exchange (Rx-type) balloon dilatation catheter composed of a balloon dilatation catheter and a drug coating. The balloon surface is coated with a drug layer containing 3μg/mm² of rapamycin, designed for the dilatation treatment of primary coronary bifurcation lesions with vessel diameters ≥2.0mm and ≤3.0mm.

The product utilizes an ultrasonic spraying process with an average spray particle size of 15μm, achieving higher uniformity, thinner coating, and superior drug control.
After screening nearly a hundred formulations, a unique excipient-free formula was selected, which maintains the resilience of the drug coating while improving drug transfer efficiency.
The distinctive crystalline structure facilitates prolonged drug retention within the vessel wall.

Product Features

1. High Drug Transfer & Prolonged Retention Technology

· The product demonstrates a drug residue rate and delivery loss rate of less than 30%, with a drug transfer rate exceeding 45%.

· In the treated vessel segment, the drug concentration in the vessel wall peaks immediately post-procedure and gradually declines over time.

· By Day 28, the drug concentration remains above 1 ng/mg, ensuring sustained therapeutic effects.

2. Optimized Drug Dosage

· The drug loading capacity is 3 μg/mm², which is on the lower end compared to similar products (typically 4 μg/mm²).

· This low yet effective dose achieves the desired therapeutic concentration without excessive drug residue, preventing delayed endothelial healing.

Clinical Outcomes

SUMPROMINENCE® demonstrated non-inferiority to the comparator device in target lesion branch vessel diameter stenosis at 9-month follow-up.

This product was evaluated through a prospective, multicenter, randomized controlled trial with non-inferiority design. The trial conducted across 10 sites in China, enrolled 236 eligible subjects, randomized 1:1 to either the test group (n=119) or control group (n=117).

In the FAS (Full Analysis Set):
At 9 months post-procedure, the target lesion branch vessel diameter stenosis was 26.78% ± 14.40% in the test group versus 30.60% ± 17.07% in the control group. Non-inferiority was established with 95% confidence interval analysis.

In the PPS (Per Protocol Set):
The target lesion branch vessel diameter stenosis at 9 months was 28.38% ± 14.66% (test group) compared to 30.57% ± 16.70% (control group), with 95% CI confirming non-inferiority.