Glubran 2
1 / 32ページ

The gentle power of a drop. Class III medical device, synthetic, CE certified for surgical and endovascular use SOLUTION COMES FROM EVOLUTION.

6 General information 8 Properties 12 Features 14 Biocompatibility 16 Safety 18Applicator Devices, Rationales and Areas of Application 24 Bibliography

GLUBRAN 2 / GENERAL INFORMATION SUPPORTING THE SURGEON, WITH BETTER RESULTS FOR PATIENTS. 25 years sustaining surgery. The evolution of GEM derives from its continuing commitment to research and efforts to improve products and demonstrate their effectiveness and quality, not only through the contribution of our expert professionals, but also through clinical studies on the most innovative devices. GENERAL SURGERY 37-84 CANCER SURGERY 61,64,66,69,73,74,82,84-86,89,94,97 UROLOGY 95-105 GYNECOLOGY "w" THORACIC SURGERY 85-92 NEUROSURGERY 20-21 DENTAL SURGERY 22,26,27,191,193,196 OTOLARYNGOLOGY...

ADHESIVE SEALANT HEMOSTATIC BACTERIOSTATIC SCLEROSING

GENERAL INFORMATION GLUBRAN 2 / GENERAL INFORMATION Glubran 2 for minimally invasive surgery. Versatile, polymerizes quickly in contact with tissue and in a moist environment 59,98,100,159 Creates a thin, elastic, breathable film, firmly adhering to tissues or prosthetic materials 2,7,30,65,84,91 UNIQUE FORMULA commercially available A second generation product modified by the addition of a monomer N-Butyl 2 Cyanoacrylate (NBCA)+ Methacryloxysulfolane (MS)

SIX properties in ONE SINGLE product, for over 80 surgical indications. ADHESIVE High tensile strength: the minimum acceptable load is 435 N [approx. 18 kg/cm2]. 1,2,13,16 SEALANT Applied using dedicated nebulizers, it forms a thin film with sealing and waterproofing properties, thanks to its synthetic nature and high adhesive power. 2,27,30,64-68,77,88,91,106-108 HEMOSTATIC Reacts with blood, even when uncoagulated, inducing "mechanical" hemostasis at the site of bleeding. 7,62,63,95-97-116-119,121-127,131-134 BACTERIOSTATIC Inhibits bacterial proliferation for an average of 7 days....

Radiology, Neuroradiology, Cardiology Interventional Cardiac surgery Gynecological surgery Digestive endoscopy Urological surgery General surgery Pediatric surgery Vascular surgery Thoracic surgery Plastic Surgery

When it makes a difference.

GLUBRAN 2 / NOT JUST A HEMOSTATIC A GREAT ADHESIVE AND EXCELLENT BACTERIOSTATIC SEALANT.* It also interacts and reacts with liquids other than blood: serum, lymph, gastric and pancreatic juices, bile, saliva, urine. Reacts with blood, even when uncoagulated, inducing "mechanical" hemostasis at the site of bleeding . 63-84,95,98-109,197 Hemostasis is ensured, even in anticoagulated patients or in patients with hereditary coagulopathies. 103,143,146,161

GLUBRAN 2 / CHEMICAL-PHYSICAL CHARACTERISTICS RELIABLE BIOCHEMISTRY. TRANSPARENT Smell TYPICAL OF CYANOACRYLATES Density Ready to use 1,7,35,37,196 Does NOT polymerize in the presence of air 142 Storage between +2 and +8 °C Can stay at room temperature (22.5+/-2.5 °C) for 5 days 1 Effective in moist environment 1,59,98,100,159 The advantages of MS: Polymerization temperature: 45 °C, much lower than 80-90 °C typical of pure monomeric cyanoacrylates 6,8,59, 98,100,159 Biocompatibility 1,2,5,7,200 NO tissue necrosis 3,7,6,172 Elasticity of the film at the end of polymerization 2,7,30,65,84,91

ions trigger polymerization unstable intermediate monomer Moist environments and tissues BLOOD or OTHER BODY FLUIDS (serum, lymph, gastric or pancreatic juices, bile, saliva, urine) Polymerizes after 1-2 seconds, complete after 60-90 sec During polymerization a thin, elastic film is formed that adapts to the anatomy of the tissues. 106-108 At the end of polymerization, the surface of the film is no longer adhesive. 8 NOTE Distilled water/glucose/mannitol do not activate polymerization 3,7,6,172 12/13

Zero residue, zero traces.

HYDROLYTIC DEGRADATION Carboxylesterases circulating in the blood BIODEGRADE Glubran® 2 by means of hydrolytic mechanisms, in a period ranging from 15 days to 6 months. The degradation products are excreted from the body through the kidneys and pulmonary excretion.65 In more vascularized tissues, elimination is faster.55,200 Glubran® 2 does not stop the healing and tissue regeneration process. The same newly formed tissue cells penetrate the film of Glubran® 2 and continue to colonize it and reproduce, until it is eliminated.55'200 Histological samples of abdominal wall cross-sections of...

BIOCOMPATIBILITY TEST 1 Cytotoxicity Genotoxicity Mutagenicity TISSUE TESTS 1 Intracutaneous reactivity on rabbit Allergic sensitization on guinea pig Muscle implantation test in rabbit RESULTS The product causes moderate inflammation, typical of foreign body reactions such as suture threads 1,7,200 NO chronic inflammation 1,3,6,7,200 Once polymerization is complete, Glubran® 2 behaves like an INERT BIOMATERIAL 1,2’7’27’78’2°2 Over 2 MLN treatments 25 years of safety Over 200 publications

“Cyanoacrylate Surgical Glue as an Alternative to Suture Threads for Mesh “Cyanoacrylate Surgical Glue as an Alternative to Suture Threads for Mesh Fixation in Hernia Repair” an alternative al., JSRJSR 2010 meshes for hernia repair." Fixation in Hernia Repair” Losi P. suture 2010 "Cyanoacrylate surgical glue as Losi P. et toet al.,stitches in fixing 7 … No PMN (PolyMorphoNucleated), necrotic cells or apoptotic cells were observed. "...when cyanoacrylates with longer alkyl chains (longer degradation) were finally synthesized, these began to be used clinically without histotoxicity..." 192

Constantly evolving solutions. G-NB-2 1 ml / 0.5 ml / 0.25 ml 10 sterile single-dose aluminum blister packs Shelf life 2 years

GLUBRAN 2 / APPLICATORS CUSTOM APPLICATIONS. Tip for thin linear application Devices for drop-by-drop applications Laparoscopic catheters for drop-by-drop application glutack Laparoscopic atraumatic fixing device for hernia prostheses