Pre clinical Data

Galaxy Therapeutics Incorporated brings nature to the bedside. Inspired by the Jellyfish. 

 Galaxy Therapeutics

  • Credits for the Above information: *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

Early Clinical Experience:

Study Design:

  • Included 29 patients with 33 aneurysms 12- month angiographic data to support US IDE trial
  • Aneurysm sizes 3mm-25mm
  • Bifurcation & sidewall aneurysms
  • Adults 20-80 years of age
  • Current enrollment 29 patients
  • Early safety data for all patients showed no morbidity, mortality, or retreatment
  • INDEPENDENT Imaging CORE LAB Results (N=33): SEALTM One year Occlusion 77.8%
Results from those who reached the follow-up time window
Core Lab Findings
Post procedure
N=33
24hr Follow-up
N=33
3-month Follow-up
N=25/33
6-month Follow-up
N=17/33
12-month Follow-up
N=9/33
Occlusion Raymond Roy (RR) Scale
Complete occlusion (RR I)
33.3% (11/33)
33.3% (11/33)
76% (19/25)
70.6% (12/17)
77.8% (7/9)
Residual Neck (R II)
18.2% (6/33)
15.2% (5/33)
8.0% (2/25)
11.8% (2/17)
0.0% (0/9)
Residual Aneurysm (R III)
51.5% (17/33)
51.5% (17/33)
16.0% (4/25)
17.7% (3/17)
22.2% (2/9)
Occlusion WEB-IT Scale
A and B Occlusion
33.3% (11/33)
39.4% (13/33)
80% (20/25)
76.5% (13/17)
78.8% (7/9)
A
30.3% (10/33)
33.3% (11/33)
76% (19/25)
52.9% (9/17)
77.8% (7/9)
B
3.0% (1/33)
6.1% (2/33)
4.0% (1/25)
23.5% (4/17)
0.0% (0/9)
C
24.2% (8/33)
21.2% (7/33)
12.0% (3/25)
11.8% (2/17)
0.0% (0/9)
D
42.4% (14/33)
39.4% (13/33)
8.0% (2/25)
11.8% (2/17)
22.2% (2/9)

SEALTM Global Registry

Contact

SEAL™ System Advantages

  • Dual layer device provides increased blood flow diversion
  • Preclinical and early clinical experience of the SEAL™ device demonstrated high rate of aneurysm occlusion
  • The soft leading edge of the SEAL™ device provides additional patient safety and allows greater ease of use and deployment
  • SEAL™ is conformable to aneurysm shape
  • Elliptical design is consistent with true aneurysm neck shape
  • Simplicity of sizing the device to the aneurysm size
  • It cover a wider range of aneurysm sizes up to 20 mm in width

SEAL™ System Intended Use and Indication

  • The SEAL™ Aneurysm Embolization System is intended for trans-arterial embolization of wide neck saccular intracranial aneurysms among adult population with maximum aneurysm width of 2.5 mm to 20 mm with neck size of equal to or greater than 4mm or neck to dome width ratio of less than 2
  • The intended therapeutic effect of the SEAL™ System is to impede the blood flow to an aneurysm sac, causing thrombus formation and clotting within the device, leading to aneurysm sac obliteration, and exclusion from the circulation

Study Design

  • Prospective, international, single-arm, multicenter, registry study
  • Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System
  • Immediate post-procedure angiographic findings, clinical presentation, safety, and standard of care imaging follow-up for each subject will be collected at 24 hours or discharge, 3 months, 6 months, and required primary end point 12 months DSA post-procedure
  • DSA at 12 months will be required imaging for the primary effectiveness endpoint assessment
  • Subjects follow up will continue annually for a total of five years post procedure with vascular imaging per the institution standard of care

Study Population

  • All adult subjects between 20 and 80 years of age and presenting with an unruptured or ruptured saccular Wide Neck intracranial aneurysm with less or equal to 20 mm in its widest diameter (2.5mm-20mm range) that in the opinion of the Principal Investigator requires treatment and suitable candidate for intrasaccular device treatment, who meet all eligibility criteria, will be considered for study enrollment
  • Up to 200 adult subjects will be enrolled in the study in up to 25 centers

Safety endpoints are the combined rate of the following:

0-30 days post-procedure

  • The rate of any major# strokes
  • Death rate of any non-accidental cause or any major stroke. (Note: major stroke leading to death will be counted once in the combined rate of major stroke and death)

31-365 days post-procedure

  • The rate of major# ipsilateral stroke
  • Neurological death rate: (Note: major stroke leading to death will be counted once in the combined rate of major stroke and death)

Secondary Safety Endpoints

  • Serious Adverse Events (SAE) associated with the device, both individually and in aggregate
  • Parent artery patency at 3, 6, 12-month follow-up when vascular imaging is available
  • All-cause mortality rate
  • Length of hospital stay

All neurological Serious Adverse Events (SAEs), including but not limited to:

  • Intracranial hemorrhage (ICH)
  • Ischemic stroke events
  • transient ischemic attacks (TIAs) regardless of worsening in the NIHSS

Primary Efficacy Endpoints

Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent imaging core lab:

  • Index aneurysm occlusion is defined as achieving WEB Occlusion Scale (WOS) of A or B at 12 months
  • Index aneurysm parent arterial stenosis is defined as diameter stenosis of >50%

Inclusion Criteria

 The index intracranial aneurysm (IA) to be treated must include the following features:

  • Aneurysm suitable for endovascular treatment with an intrasaccular device per the treating interventionist
  • Saccular morphology
  • Wide-neck: neck size ≥ 4mm or Dome-to-Neck (DN) ratio < 2
  • Bifurcation, or sidewall in the anterior or posterior circulations
  • Second/Multiple Aneurysms: Should be treated simultaneously or no less than 30 days from enrollment

Inclusion Criteria

  • 18 to 80 years of age at the time of screening
  • Unruptured aneurysm requiring endovascular treatment suitable for SEAL™ device and meet the AHA guidelines for management of unruptured aneurysm
  • If there is evidence of an additional aneurysm requiring treatment, the secondary aneurysm must also be treatable using a SEAL™ System Device, either during a single procedure or consecutive procedures

Ruptured aneurysm

Ruptured aneurysms may be included according to the following criteria:

  • The subject is neurologically stable with no seizure at the onset of the SAH, not requiring EVD placement prior to inclusion
  • Hunt and Hess scale of < 3 at the time of treatment
  • Modified Disability Scale (mRS) of ≤2 prior to presentation or aneurysm rupture
  • Meet the AHA guidelines for management of ruptured aneurysm

Inclusion Criteria

  • Aneurysm treatment does not require the preplanned use of any additional implanted devices
  • Subject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up schedule
  • Baseline pre-procedure mRS of 0-2 for unruptured aneurysm and 0-2 prior to the SAH for the ruptured aneurysms
  • Ability to obtain written informed consent from subject or legally authorized representative in SAH subjects prior to the initiation of any study procedures

Exclusion Criteria

  • Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic / infectious aneurysms
  • Aneurysms smaller than 2.5 mm and larger than 20 mm in dome width
  • Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angle take-off
  • Patients with two 360 degrees loops in the carotid or vertebral arteries
  • Presence of vascular disease or other vascular abnormality that could prohibit access to index aneurysm such carotid stenosis or diminished caliber of the target artery
  • Clinical, angiographic, or CT evidence of CNS arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma < 3 cm), or any other intracranial vascular malformations

Exclusion Criteria

  • Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy
  • Currently enrolled in another investigational study or post-market study that could affect the safety and efficacy of aneurysm treatment or interfere with the study follow-up schedule
  • Presence of an acute life-threatening illness requiring treatment
  • Life expectancy of <1 year
  • Subject has an uncontrolled co-morbid medical condition, that would adversely affect participation in the study
  • Patient with chronic kidney disease (and not on dialysis) with creatinine > 2.0
  • Subject is a prisoner or member of other vulnerable population
  • Subject that is in the opinion of the treating interventionalist is not suitable for the study

Study Subjects Screening

  • Performed by the local participating center site PI and study team listed on the IRB protocol
  • The study PI will screen the subject and document the reason for screen failure. If the subject is eligible for the study, he will sign an informed consent to participate in the study prior to participating in any study related activities
  • Prior to the procedure date, the available pre-procedure intra-cranial aneurysm images (such as MRA, CTA or DSA) should be sent to the trial management team or approving committee to make sure that the aneurysm is suitable for the device

Study flow diagram showing the study’s visit schedule and windows:

SEAL™ Device Selection

  • SEAL™ device comes in 7 sizes for SEAL™ Base and 7 Sizes for the SEAL™ Arc covering aneurysms sizes from 2.5 mm to 20 mm in width
  • To select the right device size, a careful evaluation of the aneurysm shape, morphology and exact size in the AP and Lateral planes is important the diagram below provide guidance
Serial
SEAL™ Base
Device
Device Width (mm)
Recommended Height (mm) Aneurysm Width (mm)
Recommended Aneurysm Height (mm)
General Descriptive Guidance
B1
BASE SEAL™
3
2
2.5 to $2.9
22
Small shallow aneurysms
B2
BASE SEAL™
6
2
3 to 5.9
22
Small/Medium shallow aneurysms Medium shallow aneurysms
B3
BASE SEAL™
9
3
6 to 8.9
23
Medium shallow aneurysms
B4
BASE SEAL™
12
4
9 to 11.9
24
Medium shallow aneurysms
B5
BASE SEAL™
15
5
12 to 14.9
25
Large shallow aneurysms
B6
BASE SEAL™
18
6
15 to 17.9
26
Large shallow aneurysms
B7
BASE SEAL™
20
7
18 to 20
27
Large shallow aneurysms
Serial
SEAL™ Base
Device
Device Width (mm)
Recommended Height (mm) Aneurysm Width (mm)
Recommended Aneurysm Height (mm)
General Descriptive Guidance
A1
ARC SEAL™
4
4
$3.9
24
Small elongated aneurysms
A2
ARC SEAL™
6
5
4 to 5.9
25
Small/Medium elongated aneurysms
A3
ARC SEAL™
9
7
6 to 8.9
27
Medium elongated aneurysms
A4
ARC SEAL™
12
9
9 to 11.9
29
Medium elongated aneurysms
A5
ARC SEAL™
15
12
12 to 14.9
212
Large elongated aneurysms
A6
ARC SEAL™
18
14
15 to 17.9
214
Large elongated aneurysms
A7
ARC SEAL™
20
16
18 to 20
216
Large elongated aneurysms

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