Ramot Y.,Hebrew University of Jerusalem |
Nyska A.,Tel Aviv University |
Markovitz E.,Ortho Space Ltd. |
Dekel A.,Ortho Space Ltd. |
And 4 more authors.
Toxicologic Pathology | Year: 2015
The use of biodegradable materials is gaining popularity in medicine, especially in orthopedic applications. However, preclinical evaluation of biodegradable materials can be challenging, since they are located in close contact with host tissues and might be implanted for a long period of time. Evaluation of these compounds requires biodegradability and biocompatibility studies and meticulous pathology examination. We describe 2 preclinical studies performed on Sprague-Dawley rats for 52 weeks, to evaluate clinical pathology, biocompatibility, biodegradability, and systemic toxicity after implantation of 2-layered films or saline-inflated balloon-shaped implants of downsized InSpace™ devices (termed 'test device'). The test devices are made from a copolymer of poly-l-lactide-co-âš-caprolactone in a 70:30 ratio, identical to the device used in humans, intended for the treatment of rotator cuff tears. Intra-articular film implantation and subcutaneous implantation of the downsized device showed favorable local and systemic tolerability. Although the implanted materials have no inherent toxic or tumorigenic properties, one animal developed a fibrosarcoma at the implantation site, an event that is associated with a rodent-predilection response where solid materials cause mesenchymal neoplasms. This effect is discussed in the context of biodegradable materials along with a detailed description of expected pathology for biodegradable materials in long-term rodent studies. © 2015 by The Author(s).
Satanovsky A.,Hebrew University of Jerusalem |
Ben-Eliahu S.,Harlan Biotech Israel Ltd. |
Apple D.J.,Apple Inc |
Kleinmann G.,Kaplan Medical Center
Journal of Cataract and Refractive Surgery | Year: 2011
Purpose: To evaluate the safety of a new injector, the Raysert R-INJ-04/18, for implantation of the C-flex intraocular lens (IOL). Setting: Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel. Design: Experimental study. Methods: Sixty IOLs were subdivided into 2 equally sized groups. Group A IOLs were injected using the established R-INJ-04 injector, and those in Group B were injected with the new injector. The IOLs were injected into a Petri dish. Subsequently, all IOLs and injectors were evaluated macroscopically and microscopically and then photographed under light microscopy (LM). Two IOLs in each group were randomly chosen and sent for evaluation by scanning electron microscopy (SEM) and energy dispersive analysis of x-ray. All remaining IOLs were sent for power and modulation transfer function (MTF) analysis. Results: All Group B IOLs were successfully injected without evident signs of scratching, cracks, or deposits on LM and SEM examination. In Group A, findings were confined to a singular incidence of a small deposit detected on the periphery of the posterior optical surface of the IOL, with corresponding findings detected on the injector nozzle. No signs of scratching, cracks, or deposits were found in the rest of the IOLs or injectors. The power and MTF analyses were within the normal range for all IOLs. Conclusion: The new 1.8 mm external diameter soft-tipped injector for 2.4 to 2.2 mm incisions was shown to be safe for the implantation of the C-flex 21.0 diopter IOL. © 2011 ASCRS and ESCRS.
Lipnitzki I.,Hebrew University of Jerusalem |
Ben Eliahu S.,Harlan Biotech Israel Ltd. |
Marcovitz A.L.,Kaplan Medical Center |
Ezov N.,Harlan Biotech Israel Ltd. |
Kleinmann G.,Kaplan Medical Center
Journal of Cataract and Refractive Surgery | Year: 2014
Purpose To evaluate the impact of intraocular lens (IOL) moxifloxacin presoaking time on the intraocular concentration of moxifloxacin achieved after intracameral moxifloxacin injection. Setting Harlan Biotech Israel, Rehovot, Israel. Design Laboratory study Methods Sixty eyes of 30 rabbits were divided into 2 groups after crystalline lens evacuation. In Group A (30 eyes), hydrophilic acrylic IOLs presoaked for 15 minutes in 5 mg/mL moxifloxacin were implanted. In Group B (30 eyes), the same hydrophilic acrylic IOLs presoaked in the same solution for 24 hours were implanted. Intracameral injection of 100 mcg/0.1 moxifloxacin was performed at the end of surgery in both groups. Aqueous humor samples were obtained 2, 4, 6, 8, and 10 hours after IOL implantation and were analyzed by high-performance liquid chromatography to determine the antibiotic concentration. Results Group A achieved mean postoperative moxifloxacin concentrations of 18.60 mcg/mL ± 8.80 (SD), 4.08 ± 6.03 mcg/mL, 1.50 ± 0.75 mcg/mL, 0.21 ± 0.09 mcg/mL, and 0.12 ± 0.04 mcg/mL at 2, 4, 6, 8, and 10 hours, respectively. Group B achieved mean moxifloxacin concentrations of 17.25 ± 6.27 mcg/mL, 9.46 ± 2.22 mcg/mL, 6.26 ± 1.22 mcg/mL, 4.34 ± 0.42 mcg/mL, and 3.62 ± 1.02 mcg/mL, respectively. Moxifloxacin concentrations at 6, 8, and 10 hours were statistically significantly higher in Group B than in Group A (all P <.0001). Conclusions Combining intracameral moxifloxacin injection with implantation of moxifloxacin-presoaked hydrophilic acrylic IOLs yielded high intraocular concentrations of moxifloxacin. Higher concentrations were found with longer presoaking. Financial Disclosure No author has a financial or proprietary interest in any material or method mentioned. © 2014 ASCRS and ESCRS.
Ben-Eliahu S.,Harlan Biotech Israel Ltd. |
Tal K.,Hebrew University of Jerusalem |
Milstein A.,Kaplan Medical Center |
Levin-Harrus T.,Harlan Biotech Israel Ltd. |
And 2 more authors.
Journal of Cataract and Refractive Surgery | Year: 2010
Purpose: To evaluate the protective effect of different ophthalmic viscosurgical devices on corneal endothelial cells during phacoemulsification in a rabbit model. Setting: Harlan Biotech Israel and Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel. Design: Experimental study. Methods: Rabbit eyes were randomly assigned to 3 equally sized groups. Endothelial cell counts were performed in all eyes before initiation of the study. The aqueous humor was completely replaced by Biolon (sodium hyaluronate 1.0%) in Group A, by a combination of Viscoat (sodium chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) and Provisc (sodium chondroitin sulfate 1.0%) using the soft-shell technique in Group B, and by a combination of Visiol (sodium hyaluronate 2.0%-mannitol 0.5%) and Biolon using the soft-shell technique in Group C. The eyes were exposed to alternating 10 seconds of phacoemulsification and a 10-second pause until a total exposure time of 2.5 minutes elapsed. Endothelial cell counts were repeated 3 days after surgery. Results: The study used 18 rabbit eyes, 6 in each group. Group A had the highest endothelial cell loss (13%) followed by Group B (7%), and Group C (4%). The difference in cell loss between Group C and Group A was statistically significant (P = .037). Conclusion: The study showed the efficiency and advantages of the soft-shell technique using the combination of Visiol and Biolon over Biolon alone. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. © 2010 ASCRS and ESCRS.
Borkow G.,Cupron Scientific |
Gabbay J.,Cupron Scientific |
Dardik R.,Cupron Scientific |
Eidelman A.I.,Cupron Scientific |
And 7 more authors.
Wound Repair and Regeneration | Year: 2010
Copper plays a key role in angiogenesis and in the synthesis and stabilization of extracellular matrix skin proteins, which are critical processes of skin formation. We hypothesized that introducing copper into wound dressings would enhance wound repair. Application of wound dressings containing copper oxide to wounds inflicted in genetically engineered diabetic mice (C57BL/KsOlaHsd-Leprdb) resulted in increased gene and in situ up-regulation of proangiogenic factors (e.g., placental growth factor, hypoxia-inducible factor-1 alpha, and vascular endothelial growth factor), increased blood vessel formation (p<0.05), and enhanced wound closure (p<0.01) as compared with control dressings (without copper) or commercial wound dressings containing silver. This study proves the capacity of copper oxide-containing wound dressings to enhance wound healing and sheds light onto the molecular mechanisms by which copper oxide-impregnated dressings stimulate wound healing. © 2010 by the Wound Healing Society.