Multicenter Randomized Trial Evaluating the Safety and Effectiveness of the Instylla Hydrogel Embolic System for Vascular Occlusion of Hypervascular Tumors.

In 30 seconds

This multicenter randomized controlled trial evaluated the safety and effectiveness of the Instylla Embrace Hydrogel Embolic System (HES) in adults with hypervascular tumors. The study found that HES achieved a freedom from major adverse events of 99% and a technical success rate of 88.6%, compared to 77.3% for standard of care, demonstrating its noninferiority.

Key findings

• Freedom from major adverse events was 99% for HES-treated subjects (P < .001).
• Technical success was achieved in 88.6% of HES cases compared to 77.3% for standard of care (P = .001).
• The study included 150 subjects with a mean age of 65.4 years.

Why it matters

The findings suggest that the Instylla Embrace HES is a safe and effective alternative for embolization of hypervascular tumors, potentially offering improved outcomes compared to standard treatment options.