Scientific Summary A new FDA clearance for the Aventus Thrombectomy System was officially published on
Scientific Summary
A new FDA clearance for the Aventus Thrombectomy System was officially published on
June 16, 2025, marking a key development in PE management.
1. Device Overview:
• The Aventus Thrombectomy System, developed by Inquis Medical (California), has received FDA clearance for use in treating pulmonary embolism (PE).
• It is a next-generation mechanical thrombectomy system previously approved for removing clots from peripheral arteries.
2. New Indication:
• The new FDA clearance expands its indication to include intermediate-risk PE patients, marking a significant development in PE management.
3. Clinical Evidence:
• Clearance was based on an IDE clinical study involving 120 patients across 22 U.S. sites.
• Results showed:
• No device-related major adverse events
• Significant improvement in right heart strain, a key marker in PE outcomes.
• The full results were published in JSCAI.
4. Key Innovation:
• Aventus is the only thrombectomy system with integrated tissue-sensing technology, allowing:
• Accurate clot removal
• Simultaneous blood return
• Reduced procedural complexity
• One-platform operation without requiring multiple tools
5. Intermediate-risk PE (also known as submassive PE) accounts for an estimated 30–50% of all pulmonary embolism cases. These patients are hemodynamically stable but show signs of right heart strain or myocardial injury.
Note: This information is based on guideline data and clinical registry findings, not part of the original article.
Massive PE accounts for approximately 5–10% of cases, whereas the majority of PE patients (~90–95%) fall into intermediate- or low-risk categories.
https://www.jscai.org/article/S2772-9303(25)01103-2/fulltext
