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Results for “Absorbable Implants”

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PubMed2000

Early experience with poly L-lactic acid bioabsorbable fixation system for paediatric craniosynostosis surgery. Report of 3 cases.

OBJECTIVE: The authors describe early experience in the use of bioabsorbable fixation devices for cranial reconstruction of paediatric craniosynostosis patients. METHODS: Three patients, individually respectively presenting sagittal synostosis, metopic synostosis, and clover leaf skull deformity, underwent cranial reconstruction using poly L-lactic acid (PLLA) plates and screws. The patients ranged in age from 2 to 10 months at the time of surgery. The postoperative clinical follow-up ranged from 16 to 18 months. All patients showed satisfactory wound healing without signs of infection or local inflammation. The plates provided satisfactory fixation and were not palpable through the skin after 16 to 18 postoperative months. CONCLUSION: Our experience demonstrated the efficacy of PLLA bioabsorbable plates and screws for cranial reconstruction in cases of infant craniosynostosis. Prospective studies and longer follow-up of a larger number of patients is desirable for confirmation of these findings.

Absorbable Implants↗

PubMed2004

Ectopic bone formation around the poly-L-lactide screw head in rotational acetabular osteotomy for hip dysplasia.

Ectopic bone formation around the poly-L-lactide (PLLA) screw head in eccentric rotational acetabular osteotomy for hip dysplasia was investigated. A total of 174 hips in 165 patients with hip dysplasia were consecutively treated with eccentric rotational acetabular osteotomy. Average age at the time of operation was 37 years. Acetabular fragments of 123 patients (132 hips) were fixed by Kirschner wires (K-wire group), and 42 hips in 42 patients were fixed with PLLA screws (PLLA group). There was no statistically significant difference between the backgrounds of the two groups. All patients were evaluated clinically and radiologically. In the K-wire group, ectopic bone formation of class 2 was observed in only 1 hip. In the PLLA group, ectopic bone formation of class 3 in 1 hip and class 2 in 3 hips was observed around the screw head 3 months postoperatively, and all hips but 1 showed class 2 at final follow-up. One hip with class 3 at 1 year developed marked reduction of range of motion, and this patient complained of moderate hip pain and stiffness. PLLA screws significantly enhanced ectopic bone formation around the screw head in eccentric rotational acetabular osteotomy.

Absorbable Implants↗

PubMed1999

Combining transforming growth factor-beta(1) to a bioabsorbable self-reinforced polylactide pin for osteotomy healing: an experimental study on rats.

The effect of a bioabsorbable pin containing transforming growth factor-beta(1) on fracture healing was studied in a rat model. The growth factor was mixed into a bioabsorbable polymer paste (a blend of an l-lactic acid oligomer and a copolymer of epsilon-caprolactone and dl-lactide) that was used to fill the grooves of a self-reinforced fracture fixation pin made of a poly-ld-lactic acid copolymer. In an in vitro assay, sustained release of the growth factor from the pins over a 7-day period was demonstrated. A distal femoral osteotomy was made in 60 rats and stabilized with the fracture fixation pin in 48 of them; In the remaining 12 rats, no fixation was performed. The pin used in the study group contained either 5 microg (15 rats) or 50 microg (15 rats) of the growth factor, while in a control group of 18 rats an identical pin without the growth factor was used. After a follow-up of 1, 3, or 6 weeks, the femurs were examined radiographically, histologically, histomorphometrically, and microradiographically, and also used in tetracycline labeling studies. Faster callus formation was evident in the growth factor-treated rats but no acceleration in the healing of the osteotomy was detected.

Absorbable Implants↗

PubMed2005

Five-year results of guided tissue regeneration in combination with deproteinized bovine bone (Bio-Oss) in the treatment of intrabony periodontal defects: a case series report.

The aim of this study was to report on the clinical and radiographic results 5 years following treatment of intrabony defects with guided tissue regeneration (GTR) in combination with deproteinized bovine bone (DBB) (Bio-Oss). Fifteen patients, with at least one intrabony periodontal defect with probing pocket depth (PPD)>or=7 mm and radiographic presence of an intrabony component (IC)>or=4 mm, were treated with a PLA/PGA bioabsorbable membrane. Prior to placement of the membrane, the defect was filled with DBB impregnated with gentamicin sulfate 2 mg/ml. Standardized intraoral radiographs were taken prior to treatment and at the control examinations after 1 and 5 years. At baseline, the average PPD was 9.2+/-1.1 mm, and the average probing attachment level (PAL) was 10.1+/-1.6 mm; the radiographic bone level (RBL) was 10.4+/-2.45 mm, and an IC of 6.2+/-2.3 mm was present. One year after membrane placement, treatment had resulted in a PAL gain of 3.8+/-1.8 mm, a residual PPD of 4.2+/-1.3 mm, an RBL gain of 4.7+/-2.0 mm, and a residual IC of 2.1+/-1.2 mm. At the 5-year examination, two patients did not show up, and two patients had lost the treated tooth. However, both teeth were endodontically treated, and progressive periodontal destruction might not necessarily have been the reason for extraction. At the 5-year control (11 patients), the PAL gain was 4.1+/-1.6 mm, and the residual PPD was 4.6+/-1.2 mm; an RBL gain of 4.9+/-2.7 mm and a residual IC of 1.8+/-0.8 mm were observed. Statistically significant clinical improvements had occurred between baseline and the 1- and 5-year controls, whereas there were no significant differences between the 1- and 5-year results. The results of GTR with bioabsorbable membranes in combination with Bio-Oss in the treatment of periodontal intrabony defects are basically stable on a long-term basis.

Absorbable Implants↗

PubMed2006

Comparison of the proliferative activity in gingival epithelium after surgical treatments of intrabony defects with bioactive glass and bioabsorbable membrane.

Guided tissue regeneration is based on preventing the more rapidly proliferating epithelium from growing into the periodontal defect after surgical procedures incorporating barrier membranes. The aim of this study was to compare the proliferative activity of gingival epithelium using proliferating cell nuclear antigen (PCNA) as a marker of cell proliferation after surgical treatments with bioactive glass graft material and bioabsorbable membrane. Using split mouth design, 20 intrabony defects were randomly assigned treatments with bioactive glass (BG group) or bioabsorbable membrane (BM group). Gingival biopsies were taken at preoperative and postoperative 12 weeks. After histological processing, the number of the inflammatory cells was measured in hematoxylin and eosin-stained sections; PCNA expression was determined in immunohistochemically-stained sections. At postoperative 12 weeks, the number of the inflammatory cells was significantly decreased (p < 0.01), PCNA expression was significantly increased (p < 0.001) in both treatment groups compared to baseline data. There was no significant difference in PCNA expression between baseline values of two groups (p > 0.05), while at postoperative 12 weeks, increase in BG group was significantly greater than that in BM group (p < 0.001). These results suggest that epithelial cell proliferation is more prominent after treatment of intrabony defects with bioactive glass compared to the treatment with bioabsorbable membrane.

Absorbable Implants↗

PubMed2000

Compatibility of resorbable and nonresorbable guided tissue regeneration membranes in cultures of primary human periodontal ligament fibroblasts and human osteoblast-like cells.

The purpose of this study was (a) to evaluate the cytocompatibility of three resorbable and nonresorbable membranes in fibroblast and osteoblast-like cell cultures and (b) to observe the growth of those cells on the various barriers by scanning electron microscopy (SEM). Primary human periodontal ligament fibroblasts (HPLF) and human osteoblast-like cells (SAOS-2) were incubated with nonresorbable polytetrafluoroethylene (ePTFE) barriers and resorbable polylactic acid as well as collagen membranes. Cytotoxic effects were determined by XTT (mitochondrial metabolic activity) and sulforhodamine B assays (cellular protein content). In addition, HPLF and SAOS-2 grown for 21 days on the investigated barriers were evaluated by SEM. Data were analyzed statistically by ANOVA using the Wilcoxon-Mann-Whitney test (P < 0.05). No changes were established in the periodontal ligament fibroblasts and human osteoblast-like cells after incubation with the collagen membrane. Cytotoxic effects, however, were induced by the polylactic acid barrier which slightly inhibited cell metabolism of the periodontal fibroblasts (XTT: 90.1% +/- 3.6 of control value). Moderate cytotoxic reactions were caused by the nonresorbable ePTFE membrane in HPLF-cultures (XTT: 82.7% +/- 3.5) and osteoblast-like cell monolayers (XTT: 80.0% +/- 0.6%). Mitochondrial activity in both cell cultures was significantly reduced by ePTFE barriers in comparison to non-incubated control cells (P = 0.028). SEM analysis of cell behavior on barriers demonstrated the differences between these materials: collagen barriers were densely populated with HPLF and SAOS-2, whereas only few or no cells were seen to adhere to the ePTFE and polylactic acid membranes. Our findings indicate that the collagen barrier investigated is very cytocompatible and may be integrated into connective tissue well. On the contrary, the ePTFE and polylactic acid membranes induced slight to moderate cytotoxic reactions which may reduce cellular adhesion. Thus, gap formation between the barrier surface and the connective tissue may be promoted which may facilitate epithelial downgrowth and microbial accumulation. Consequently, these effects may reduce the potential gain in periodontal attachment.

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PubMed2000

Healing of fenestration-type defects following treatment with guided tissue regeneration or enamel matrix proteins. An experimental study in monkeys.

The aim of the present study was to evaluate histologically in monkeys the healing in acute fenestration-type defects following treatment with guided tissue regeneration (GTR) or enamel matrix proteins (EMD). Standardized "critical size" fenestration-type defects were produced surgically at the vestibular aspect of teeth 13, 23, 33, 43 in three monkeys (Macaca fascicularis). The vestibular bone plates were removed and the root surfaces were debrided by means of hand instruments in order to completely remove the root cementum. Following root conditioning with ethylenediaminetetraacetate (EDTA), the defects were treated using one of the following therapies: (1) GTR, (2) EMD, or (3) control (coronally repositioned flaps). After 5 months the animals were killed and perfused with 10% buffered formalin for fixation. Specimens containing the defects and surrounding tissues were dissected free, decalcified in EDTA, and embedded in paraffin. Eight-micrometer-thick step serial histological sections were cut in a vestibulo-oral direction, stained with hematoxylin and eosin or oxone-aldehyde-fuchsin-Halmi, and subsequently examined under the light microscope. The results showed that, in the defects treated with GTR, a new connective tissue attachment (i.e., new cementum with inserting collagen fibers) and new bone formation had consistently occurred, whereas, in the defects treated with EMD or with coronally repositioned flaps, new attachment and new bone reformed to a varying extent. The quality of the cementum did not differ after EMD, GTR, or flap surgery. It was concluded that GTR treatment with bioresorbable membranes seems to predictably promote new attachment and new bone formation, whereas the application of EDTA or EMD may also enhance periodontal healing to a certain extent. Further studies with higher numbers of animals and defects are needed in order to definitely clarify the effect of root surface conditioning with EDTA and EMD on periodontal healing.

Absorbable Implants↗

PubMed2002

[Individually CAD-CAM technique designed, bioresorbable 3-dimensional polycaprolactone framework for experimental reconstruction of craniofacial defects in the pig].

METHODS: Twenty orbital defects (2 x 2 cm) were created in ten adult Yorkshire pigs. Two software products (Velocity and Mimix) were evaluated with regard to image processing, three-dimensional reconstruction, and fabrication of individually shaped polycaprolactone (PCL) scaffolds to reconstruct these defects. Four different techniques were tested for the reconstruction: group 1 = no reconstruction, group 2 = polylactide sheet, group 3 = PCL scaffold, group 4 = bone marrow-coated PCL scaffold. The pigs were sacrificed at 3 months. RESULTS: In group 1 soft tissue scar formation could be found, but without any new bone. Group 2 showed a thick fibrous capsule around the PLLA sheet, whereas at the border zone of the defect signs of new bone formation could be detected. In group 3 the PCL scaffolds were filled with fibrous tissue and some areas that showed new bone formation (6.4% of the area of the defect). In group 4 the new bone formation (17.8% of the area of the defect) was significantly higher in quantity than in group 3. CONCLUSION: The PCL scaffold coated with bone marrow seems to be a material that effectively provides osteoinduction with formation of new bone. Long-term results at 12 months are still pending.

Absorbable Implants↗

PubMed2003

[Memory effect of resorbable polymers].

BACKGROUND: The present study analyzed the memory effect of resorbable polymers. Depending on temperature, this effect describes the ability of different materials to "remember" their original form after mechanical deformation. Resorbable polymers serve as materials to stabilize and fix bone fractures. Compared to metal transplants, resorbable polymers are able to undergo thermoplastic deformation. The precise adaptation of the transplant to the surrounding bone guarantees an exact anatomical reconstruction. However, during normal applications, it was observed that these biodegradable plastic materials tend to revert to their original form at body temperature. This "memory effect" could result in negative consequences for the medical treatment. METHODS: By the process of compression molding, geometrically formed specimens (lattice, rod, plate) consisting of different polyglycolides and polylactides were prepared. After warming up the specimens to 50 degrees C (water bath) they were deformed into definite angles. Following this procedure, the specimens were put in a water bath at 37 degrees C to mimic the adaptation of the transplant at body temperature. The retroflexion of the material (memory effect) was measured using an XY-measuring desk. RESULTS: The present study clearly reveals that highly deformed specimens react with stronger retroflexions. In addition, the results indicate that the memory effect depends on geometrical design as well as on chemical composition. All tested polymers showed a strong initial memory effect that decreased with time.

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PubMed2004

[Stability of osteosyntheses for condylar head fractures in the clinic and biomechanical simulation].

BACKGROUND: Fractures of the condylar head are traditionally managed by closed techniques, despite a considerable rate of dysfunctional problems. PDS pin osteosynthesis (presented by Rasse 1992) via a preauricular approach failed to become established as a standard procedure due to a lack of stability. Alternatively, mini- or microplating, as performed in our patients (101 condylar head fractures between 1993 and 2000), showed high-grade limitations of translatory movements in about 30% due to scarification after loosening of osteosynthesis materials. The aim of this study was to establish an efficient procedure for achieving a functionally stable and atraumatic osteosynthesis. METHODS: For the definition of a suitable procedure, models of the mandible (standardized fractures, types A, B, and C) were osteosynthesized (six samples for each type of fracture and type of screw), each with three PDS pins, 2.0 mm resorbable, 2.0 cortical, 1.7 and 1.2 mm small fragment screws, and exposed to increasing loads in centric (0-20-35 mm opening) and eccentric (35 mm opening) condylar positions. A computerized biomechanical test stand allowed a dynamic simulation of chewing forces (16 hydraulic drives). The resulting fracture gaps were measured without contact by a motion capture system. RESULTS: Within physiological limits, only 1.7 small fragment and 2.0 mm cortical screws were able to bear occlusal loadings up to 200 N (1.2 mm small fragment screws up to 150 N, resorbable 2.0 mm screws up to 100 N, and PDS-pins up to 50 N). In a pullout experiment (condylar spongious bone of young pigs, aged 4-6 months), 1.7 mm small fragment screws showed superior retention. A consecutively developed small fragment screw-system has been applied clinically in 74 condylar head fractures (58 patients). After removal of osteosynthesis material, 41 of 49 TM joints have so far shown complete restitution. CONCLUSIONS: The newly developed osteosynthesis system using a retroauricular approach based on 1.7 mm small fragment screws makes maxillomandibular immobilization unnecessary. The extra-articular position of the screw heads prevents scar-induced articular limitations. Preexisting degenerative alterations of the TMJ soft tissues, however, will affect functional results adversely.

Absorbable Implants↗

PubMed2004

[The use of a resorbable, synthetic membrane for the elevation of the sinus floor].

The elevation of the sinus floor is a routine procedure in pre-implantological surgery. We report about our experience utilizing a resorbable, synthetic membrane (Ethisorb-Patch) for stabilization of the new generated floor of the sinus and for covering minor perforations of the sinus mucosa. Due to the easy handling and the good clinical results the use of the Ethisorb-Patch during sinus floor augmentation can be recommended.

Absorbable Implants↗

PubMed2004

[Novel calcium phosphate formula for filling bone defects. Initial in vivo long-term results].

BACKGROUND: Up to now hydroxyapatite (HA) and beta-tricalciumphosphate (beta-TCP) ceramics have been routinely sintered at temperatures between 1100 degrees and 1500 degrees C. Our new calcium ceramic is fabricated by a sol-gel process at 200 degrees C. The aim of this investigation was to test the biodegradation of and the induction of bone formation by this material. MATERIAL AND METHODS: Eighteen 1-year-old Goettingen minipigs were divided into three groups. Critical size defects (>5 cm(3)) in the mandible were treated differently in all three animals (group 1: filling with 40% beta-TCP plus 60% HA, group 2: pure HA was applied, group 3 served as controls: only gelatinous material was given). Macroscopic and microscopic investigations of the former defects were made 8 months postoperatively. RESULTS. In groups 1 and 2 biodegradation of more than 93% of the new calcium phosphate formula was found 8 months postoperatively and considered to be very good. No difference was observed between pure HA (group 2) and the combination of HA and beta-TCP (group 1). In both groups complete bone formation was seen macroscopically in the former defects. In the control group only incomplete bone formation with 48.4% of the defect area was noted. This difference was significant ( p<0.001). DISCUSSION: The new calcium phosphate formula made by a sol-gel method at 120 degrees C seems to be suitable for filling bone defects and is of interest for orthopedic surgery, traumatology, craniomaxillofacial surgery, and dentistry.

Absorbable Implants↗

PubMed1998

[Absorbable and bioconvertible osteosynthesis materials in maxillofacial surgery].

In order to overcome the need for secondary intervention to remove metallic osteosynthesis devices after fracture healing, endeavours have been directed towards developing resorbable osteosynthesis materials during the last decade. The resorbable material must fulfil a number of basic demands. For example, an adequate holding strength of these materials is essential for undisturbed fracture union, complete resorption after bone healing, good histocompatibility without any damage to the surrounding tissues and without detrimental distant effects within the organism. Suggested materials are primarily high-polymerlactic acid or glycolic acid compounds. In particular, research was concentrated on the enhancement of the mechanical properties and biodegradation of polylactides. Debris high in crystallin was found to be responsible for late soft tissue reactions. To achieve disintegration products with lower crystallin content stereocopolymeres of lactic acids are preferred nowadays. Based on our experimental work, another osteosynthesis system manufactured from autoclaved allogenic bone tissue was developed as an alternative. This has osteoconductive properties and converts by creeping substitution into bone. In contrast to metallic plates and screws, the modulus of elasticity is quite similar to vital bone tissue. The initial strength enables its use in the field of maxillofacial surgery.

Absorbable Implants↗

PubMed1999

[Preliminary results of the use of resorbable plates and screws in craniofacial surgery].

In ten patients with craniosynostoses resorbable plates and screws (Lactosorb) consisting of poly-L-lactic acid (82%) and poly-glycolic acid (18%) were used to stabilize the segments after frontoorbital advancement. As our experience increased, an exact adaptation of the plates and simple handling proved to be possible. The plates were stable enough to retain a favorable functional and aesthetic result after redraping the soft tissue envelope. In one patient with Chotzen's syndrome the intended use of the resorbable material was abandoned: the thin osseous structures did not offer enough primary stability to the high pitch of the screws. During an observation period of up to 21 months no infection, exposure, instability or dislocation was observed. The clinical use of the resorbable material in frontoorbital advancement proved to be a stable method of segment fixation if the bone was of sufficient thickness. These promising preliminary results will have to observed in a larger group and over a longer period of time.

Absorbable Implants↗

PubMed2002

Temporary closure of the abdominal wall (laparostomy).

The definitive closure of the abdominal wall, i.e., a closure of the fascial layer and skin may not be favorable in the treatment of numerous surgical conditions, e.g., peritonitis, trauma, or mesenteric ischemia. In these cases, the abdominal wall is temporarily closed, and a laparostomy is created to facilitate re-exploration or to prevent abdominal compartment syndrome. Regarding the technique and material used for the temporary closure, no prospective randomized data exists, but mesh materials are commonly used. They provide drainage of infectious material, permit visual control of the underlying viscera, facilitate access to the abdominal wall, preserve the fascial margin, enable healing by secondary intention, and allow mobilization of the patient. In the case of decreasing intra-abdominal pressure, meshes can be trimmed to centralize the rectus muscle and to facilitate definitive closure. Non-absorbable meshes have been frequently reported to cause enteric fistulae and persistent infection necessitating mesh explantation. While these infectious complications appear to occur less frequently with the use of absorbable materials, these meshes will finally lead to an incisional hernia, requiring repair with non-absorbable mesh after a period of 6-12 months. Nevertheless, in the complex situation requiring a temporary abdominal wall closure, use of absorbable mesh material is common and represents the state of the art.

Abdominal Cavity↗

PubMed2004

Lichtenstein repair of inguinal hernia with Surgisis inguinal hernia matrix soft-tissue graft in immunodepressed patients.

While polypropylene mesh remains the preferred prosthesis material for hernioplasties, there are some problems with infections, intestinal obstruction and fistulization, and migration particularly in immunodepressed patients. A new degradable and reabsorbable material, the porcine small intestinal submucosa (Surgisis) has been developed for hernia repairs in humans. This prospective study evaluated the safety and efficacy of Lichtenstein hernioplasty using the Surgisis inguinal hernia matrix soft-tissue graft as a mesh in ten immunodepressed subjects. Six subjects were HIV-positive in the immunodepressive phase, and the other four had undergone transplantation (three kidney, one liver). There were no intraoperative or postoperative complications, recurrences, or wound infections. Thus Lichtenstein's hernioplasty using the Surgisis inguinal hernia matrix soft-tissue graft in immunodepressed patients promises safety and efficacy.

Absorbable Implants↗

PubMed2005

Preparation and properties of ProNectin F-coated biodegradable hollow fibers.

ProNectin F-coated biodegradable hollow fibers were newly prepared and their cytocompatibility was evaluated in vitro. Although the coating efficiency onto poly(L-lactic acid) (PLLA) and poly(lactide-co-caprolactone) [p(LA/CL)] matrices was similar, the cell adhesion properties were greatly affected by the nature of the polymer substrate. ProNectin F-coated PLLA showed about seven times higher cytocompatibility than ProNectin F-coated p(LA/CL). The single-extruded melt spinning method and the core-sheath bicomponent melt spinning method were employed to prepare PLLA hollow fibers. The effect of the spinning conditions, such as the melt draw ratio, spinneret temperature, and take-up speed, on the diameter and wall thickness of the spun fibers was studied in detail. For single-extruded melt spinning, a segmented type of spinneret was used, and the effect of the flow rate of nitrogen, which was confined in the hollow part of fibers, was studied. X-ray photographs of the drawn hollow fibers, clarified the significant molecular orientation, which was much higher than that in drawn solid PLLA fiber under identical drawing conditions. The morphology and mechanical properties of hollow fibers demonstrated an increase in the tensile strength and a decrease in the thickness of the PLLA wall with increased nitrogen flow rates and melt draw ratios for single-extruded melt spinning. These results indicate the unique characteristics of ProNectin F-coated PLLA hollow fibers, which can be successfully utilized as a biodegradable substrate.

Absorbable Implants↗

PubMed2006

Bioabsorbable staple-line reinforcement to reduce staple-line bleeding in the transection of mesenteric vessels during laparoscopic colorectal resection: a pilot study.

BACKGROUND: Staple line hemorrhage and leak are the 2 most dreaded complications of laparoscopyassisted resection of colorectal cancer (LARCC). Recently, anastomotic staple lines have been reinforced with a range of absorbable and non-absorbable bioprosthetic reinforcement materials. This pilot prospective study used the bioabsorbable Seamguard (BSG; WL Gore & Associates, Flagstaff, AZ) for routine reinforcement of the mesenteric vascular staple transection to prevent mesenteric hemorrhage and to assess its safety and feasibility in a consecutive series of laparoscopic colonic resections. METHODS: Twenty-five patients consecutively scheduled to undergo LARCC were enrolled in the study. All operations were performed with a standard LARCC technique which included loading of the BSG sleeves onto the jaws of the cutter/stapler. RESULTS: There were 23 wholly LARCC cases and 2 open conversions. BSG was used in all 25 patients. No patient experienced staple-line bleeding or other complications during the surgical procedure. The mean number of staple-line reinforcement sleeves used was 2.6 (range, 2-4). The mean operative time was 118 minutes (range, 65-184 minutes). Additional measures to achieve hemostasis were not required in any case. The mean cost was US 475.20 dollars for the procedure. CONCLUSIONS: This small pilot study has shown the routine use of BSG mesenteric staple line reinforcement to be safe, quick and effective during LARCC.

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