The SEAL™ Embolization System, including SEAL™ Base and SEAL™ ARC, has received CE marking under the European Union Medical Device Regulation (EU MDR 2017/745).
At Galaxy
Therapeutics, we
are inspired by the
intersection of
nature and
medicine to
pioneer
transformative
solutions for
the treatment of brain
aneurysms.
European Union: The SEAL™ Embolization System is CE marked under Regulation (EU) 2017/745. Product availability is subject to applicable local requirements.
United States: CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.
Refer to the applicable Instructions for Use for indications, contraindications, warnings, precautions, and device sizing information.
High density mesh promotes faster
early thrombosis¹.
Fits a broad range of
aneurysm morphologies.
Oversize² with confidence for
ultimate conformability.
No lead-in marker band for
fast, easy placement.
Treat 2 – 19mm
aneurysms with just 7 sizes.
For quick, easy placement.
1. Bench testing. Results may vary and may not necessarily be indicative of clinical performance. Testing by: Z Vardar, RM King, A Kraitem, ET Langan, LM Peterson, BH Duncan, C Raskett, V Anagnostakou, MJ Gounis, AS Puri, and GJ Ughi. High Resolution Image-Guided WEB Aneurysm Embolization by High Frequency Optical Coherence Tomography. J Neurointerv Surg 2021; 13(7):669-67 PMID: 32989033.
2. As compared to the WEB device. Data on file.
3. See instructions for use for sizing recommendations.
Galaxy Therapeutics is a clinical-phase startup founded and led by a group of seasoned neurointerventionalists dedicated to streamlining intrasaccular flow diversion. Supported by a team of accomplished engineers and neurovascular experts, we relentlessly pursue the transformation of patients’ lives.
Galaxy Therapeutics has achieved CE marking for the SEAL™ Embolization System, marking a major milestone in bringing our intrasaccular technology to physicians and patients in Europe.
The certification covers SEAL™ Base and SEAL™ ARC
Following CE marking of the SEAL™ Embolization System, Galaxy is advancing its commercial infrastructure to support European market access.
Contact our team for information about local availability, distribution, and physician training.
