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

Overview

Basic Info

Drug Type

Blood components

Synonyms

BIOSTAT BIOLOGX

Target

fibrin

Action

modulators

Mechanism

fibrin modulators(Fibrin modulators)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal DiseasesOther Diseases

Active Indication-

Inactive Indication

Intervertebral Disc DiseaseLow Back Pain

Originator Organization

Spinal Restoration, Inc.

Active Organization-

Inactive Organization

Spinal Restoration, Inc.

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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To investigate the histomorphometric performance of two-stage maxillary sinus floor elevation (TMSFE) with various bone substitutes in the treatment of atrophic posterior maxilla. Four databases (PubMed, Embase, Web of Science, and The Cochrane Library) were searched from the beginning of database establishment to August 8, 2023. The included articles were limited to the English language. A systematic search was performed to identify randomized controlled trials assessing the histological performance of various biomaterials in TMSFE with a follow-up of 5-8 months. The main outcome was an area of new bone, and an additional outcome was residual graft material. Extracted data were analyzed by using a Bayesian approach (the Markov chain Monte Carlo) to establish ranks of various biomaterials in R language. Finally, the search identified 22 studies that reported 22 trials on bone area (17 kinds of biomaterials) and 12 studies on residual graft materials (12 kinds of biomaterials) after the exclusion of one study disconnected from the network plot. No local inconsistency could be found in studies regarding bone formation, while no closed loop was detected in residual graft material. The top 3 probabilities of biomaterials in terms of bone formation were Allograft + Xenograft (AG + X) (87.14%), X + Polymer (75.69%), and Autogenous Bone + Bioactive Glass (AB + BG) (71.44%). AG + X had the highest probability (87.14%) of being the most optimal treatment for bone formation. Biphasic calcium phosphate + Fibrin sealant (BCP + FS) was ranked as the slowest absorbing biomaterial (78.27%) in TMSFE. Within the limitations of the current network meta-analysis, AG + X may represent an optimal biomaterial for bone formation in TMSFE. The use of X in combination with other biomaterials demonstrates superior osteogenic effects in TMSFE. BCP + FS exhibited strong mechanical properties during a short-term observational period. The present findings suggest that AB is not the only feasible standard for bone grafts.

01 Jun 2024·Updates in surgery

Pedicle stabilization with fibrin sealant in DIEP flap breast reconstruction

Article

Author: Marrella, Domenico ; Ciancio, Francesco ; Stagno D Alcontres, Francesco ; Ranno, Rosario ; Catalano, Francesca ; Lombardo, Giuseppe A G ; Musmarra, Isidoro ; Stivala, Alessio

Microsurgical procedures are nowadays routinely performed worldwide in reconstructive surgery. The deep inferior epigastric artery perforator (DIEP) flap has become the gold standard in breast reconstruction due to its excellent outcomes and lower donor site morbidity. However, complications, including flap failure, still occur in DIEP flap breast reconstruction. Often, according to our experience, these complications result from pedicle disorders, which can be attributed to postoperative mobilization. In the present study, we evaluated the efficacy and safety of using a fibrin sealant as a method for pedicle stabilization to prevent pedicle mobilization in the postoperative period. With our technique, after the flap insetting and microsurgical anastomosis, the pedicle was stabilized by applying a fibrin sealant (TISSEEL™) around and over the entire pedicle. Our study included a homogeneous series of 70 patients who received a delayed DIEP flap breast reconstruction. A retrospective study was conducted to evaluate this novel technique compared to the conventional method. In our experience, the fibrin glue allowed us to reduce the strain for correct pedicle positioning and all subsequent efforts to avoid displacements in the postoperative period. Our preliminary results suggest that this method may lead to a reduction in overall complications attributable to pedicle disorders.

01 Oct 2023·Surgical endoscopy

Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial.

Article

Author: Birnie, E ; Biter, L U ; 't Hart, J W H ; Apers, J A ; Huisbrink, J ; Wijnand, J M A ; Verbrugge, S J C ; Dunkelgrun, M ; Noordman, B J

INTRODUCTION:

In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG).

METHODS:

In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality.

RESULTS:

In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien-Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported.

CONCLUSION:

This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications.

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 Disease	Phase 3	United States	Spinal Restoration, Inc.	01 Mar 2010
Low Back Pain	Phase 3	United States	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 \| Intervertebral Disc Disease	220	BIOSTAT BIOLOGX (BIOSTAT BIOLOGX)	boafioydsy = mavlslmspn carntynwpt (awuqycisfd, evkjlleoep - qmpozyzaef) View more	-	05 May 2014
NCT01011816 (CTgov)	Phase 3		220	Saline (Saline)	boafioydsy = baqddavhot carntynwpt (awuqycisfd, lmjaoeseou - dwsdwmswot) View more	-	05 May 2014
ARVO2008	Not Applicable	-	114	Fibrin Sealant (Suture)	qxucxdnljf(rqjpzovflt) = stzmkgkvmo xkujfdmcov (mlqrslccsj ) View more	Positive	01 May 2008

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Biosimilar

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