Delving into the Latest Updates on Fibrin Sealant (Spinal Restoration) with Synapse

Overview

Basic Info

Drug Type

Blood components

Synonyms

BIOSTAT BIOLOGX

Target

fibrin

Mechanism

fibrin modulators(Fibrin modulators)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Intervertebral Disc DegenerationLow Back Pain

Originator Organization

Spinal Restoration, Inc.

Active Organization-

Inactive Organization

Spinal Restoration, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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The aim of this retrospective study was to assess the efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) with hydroxyapatite (HA) granules and fibrin sealant (FS) in maxillary sinus floor augmentation (MSFA), with a focus on the volume change. Fifty-two of 137 patients who underwent MSFA with rhBMP-2/HA grafting between June 2016 and December 2022 met the study inclusion criteria; 25 had received rhBMP-2/HA without FS and 27 had received rhBMP-2/HA with FS. Computed tomography (CT) images were obtained preoperatively, immediately following the operation, and at 6 months postoperative. These images were three-dimensionally reconstructed to measure the volumetric and height changes following MSFA. The mean ± standard deviation percentage of volumetric change at 6 months was 48.75 ± 37.44% in the group with FS and 29.77 ± 13.42% in the group without FS (P = 0.019). The vertical height measured at a specific site of the grafted area showed a mean percentage change at 6 months of 4.05 ± 12.08% in the group with FS and 6.07 ± 10.15% in the group without FS (P = 0.518). The additional use of FS as a carrier for rhBMP-2/HA in MSFA was found to improve surgical convenience and bone regeneration ability.

01 Sep 2024·Journal of glaucoma

The Efficacy of Fibrin Sealant in Sutureless Deep Sclerectomy—Preliminary Outcomes

Article

Author: Netukova, Magdalena ; Rosina, Jozef ; Vranova, Jana ; Studeny, Pavel ; Pluhovsky, Patrik ; Holubova, Lucie ; Urbaniova, Katarina ; Pencak, Martin ; Baxant, Alina-Dana

Précis::

Deep sclerectomy (DS) with fibrin adhesive can constitute a safe alternative to the classic procedure using sutures, providing nonallergenic, nontoxic, and secure adhesion with no sign of aqueous humor outflow obstruction postoperatively.

Objective::

To evaluate short and medium-term postoperative results of DS with a fibrin sealant.

Patients and Methods::

This prospective, noncomparative, interventional case series involves 12 eyes of 12 patients with uncontrolled open angle glaucoma who underwent DS with Esnoper (Clip or V2000) implant between February 2021 and March 2022. A novel method of wound closure (sclera, Tenon fascia, and conjunctiva) employing fibrin glue was used instead of classic sutures. Surgical outcomes assessed include: intraocular pressure and glaucoma therapy reduction, best-corrected visual acuity changes, and number of complications registered peri and postoperatively. All measurements were performed preoperatively, as well as at 1 day, at 1 and 2 weeks, and at 1, 2, 3, 6, 9, and 12 months after surgery.

Results::

The mean intraocular pressure decreased from 24.0 ± 9.1 mm Hg to 13.8 ± 6.3 mm Hg at 1 year postoperatively (P < 0.001). Kaplan-Meier survival analysis revealed complete and qualified success rates of 83.3% and 91.7%. The mean glaucoma therapy decreased from 3.2 ± 1.1 to 0.8 ± 1.3 drugs 12 months after surgery (P < 0.001). Nd:YAG goniopunture was performed in 2 eyes at 1 and 12 months postoperatively. No significant best-corrected visual acuity changes were registered. Perioperatively, we noted a trabeculo-descemet microperforation in 1 eye, transient hypotony in 5 eyes, and mild hyphema in 2 eyes.

Conclusions::

Fibrin adhesive provided an effective closure in sutureless DS in the patients included in our study. This modification of classical DS may simplify the surgical technique, ensure secure wound adaptation, optimize healing, and lower the risk of inflammation and fibrosis postoperatively.

01 Aug 2024·Journal of neurosurgery

Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial

Article

Author: Van Calenbergh, Frank ; Van Hoylandt, Anaïs ; Coucke, Birgit ; van Loon, Johannes ; De Vleeschouwer, Steven ; Van Gerven, Laura ; Theys, Tom

OBJECTIVE:

CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events.

METHODS:

In a single-blinded, prospective, randomized controlled interventional trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio.

RESULTS:

Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI −∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI −∞ to 1.96) and meningitis (0.36, 95% CI −∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI −∞ to 4.66).

CONCLUSIONS:

Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost.Clinical trial registration no.: NCT03812120 (ClinicalTrials.gov).

100 Deals associated with Fibrin Sealant (Spinal Restoration)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Intervertebral Disc Degeneration	Phase 3	US	Spinal Restoration, Inc.	01 Mar 2010
Low Back Pain	Phase 3	US	Spinal Restoration, Inc.	01 Mar 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01011816 (CTgov)	Phase 3	Intervertebral Disc Degeneration \| Low Back Pain	220	BIOSTAT BIOLOGX (BIOSTAT BIOLOGX)	vrxoyxeeiw(fgupqokzhc) = mwobvsierg mbijhdnvbu (octhmewoav, dfzgforbic - fxuibqytsl) View more	-	05 May 2014
NCT01011816 (CTgov)	Phase 3	Intervertebral Disc Degeneration \| Low Back Pain	220	Saline (Saline)	vrxoyxeeiw(fgupqokzhc) = wgrfegretn mbijhdnvbu (octhmewoav, kwmylkmlpr - ybrukenplp) View more	-	05 May 2014
NCT01649505 (CTgov)	Not Applicable	Postoperative Complications \| Seroma \| Breast Cancer	2	breast reconstruction+fibrin sealant (Beriplast P, TISSEEL VH) (Arm I (Fibrin Sealant))	bdtrlbfrzh(phqfcffxwm) = nmntpisroj odhqsdrgdf (dyxwnhxggh, peffibqifb - plxidqwjuw) View more	-	15 Mar 2013
NCT01649505 (CTgov)	Not Applicable	Postoperative Complications \| Seroma \| Breast Cancer	2	breast reconstruction (Arm II (Standard Electrocoagulation))	bdtrlbfrzh(phqfcffxwm) = bjbebfmfsi odhqsdrgdf (dyxwnhxggh, bznrcahulw - wejroqkmox) View more	-	15 Mar 2013
AHNS2012	Not Applicable	-	120	Saline control	rgoapezurk(guobnwvyxm) = vopxessqnf jxqggwcumo (etzbhgkylx )	Positive	22 Jul 2012
ARVO2008	Not Applicable	-	114	Fibrin Sealant (Suture)	cwmjpywkhv(dvceypavyd) = yshkrdvbqg fznknslkne (cxckvdjaji ) View more	Positive	01 May 2008