Endovascular Engineering Obtains IDE Approval from the US FDA for its Hēlo Thrombectomy System to Treat Pulmonary Embolism
Shots:
- Following the conclusion of the 25-patient feasibility study, the US FDA has granted Investigational Device Exemption (IDE) approval to Endovascular Engineering’s Hēlo Thrombectomy System for conducting (ENGULF) study in the US
- The (ENGULF) trial aims to investigate the safety and efficacy of the Hēlo Thrombectomy System for the treatment of pulmonary embolism (PE)
- The Hēlo Thrombectomy System employs a dual-action methodology taking place within a self-expanding funnel, as the high-speed agitator actively engages and removes clots under physician-controlled suction
Ref: PR Newswire | Image: Endovascular Engineering
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
