Animal Feasibility Study of a Novel Spinal Cord Stimulation Multicolumn Lead (Heron Lead).

BACKGROUND: Currently available spinal cord stimulation paddle leads require a laminectomy, limiting the types of clinicians who can implant and increasing the risk of complications. Recently, WISE S.r.l. designed a prototype multicolumn lead named the Heron® lead that can be implanted percutaneously. The purpose of the study was to examine the efficiency of placing a paddle lead percutaneously. METHODS: Ten sheep were assigned to either the Heron lead group (n = 7) or the control group (n = 3). The sheep were observed for 13 weeks after implantation. Neurological and clinical examinations were conducted prior to surgery and then during the follow-up period. The implantation sites were evaluated through macroscopic observations during the article explantation and the lead migration was evaluated by comparing the article positioning at the surgery, four weeks after the surgery and at the explantation day through fluoroscope images. A qualitative comparison was made between the results collected with the test article and the control article. RESULTS: Observations at the surgical sites indicate that test animals appeared to have less swelling around the surgical wound than control ones in the first 14 days, but no impact on wound healing was noticed. Additionally, no clear difference was observed in pain scores between the two groups, with observations tending to show that the maximum pain was occurring later in the test group with respect to the control group. General clinical observations showed no major difference between the two groups, and determined clinical abnormalities were not directly related to the procedure. Lastly, neurological deficits frequency decreased from the first to last animal operated, regardless of their test or control status. CONCLUSIONS: Our study concluded that the Heron lead is safe to implant, with a safety profile similar to the control article. Additionally, we conclude that the Heron lead is effective in reducing lead migration events.

Recording Electrical Brain Activity with Novel Stretchable Electrodes Based on Supersonic Cluster Beam Implantation Nanotechnology on Conformable Polymers.

BACKGROUND: Multielectrodes are implanted in central and peripheral nervous systems for rehabilitation and diagnostic purposes. The physical resistance of intracranial devices to mechanical stress is critical and fractures or electrode displacement may occur. We describe here a new recording device with stretchable properties based on Supersonic Cluster Beam Implantation (SCBI) technology with high mechanical adaptability to displacement and movement. RESULTS: The capability of SCBI-based multichannel electrodes to record brain electrical activity was compared to glass/silicon microelectrodes in acute in vitro experiments on the isolated guinea pig brain preparation. Field potentials and power frequency analysis demonstrated equal recording features for SCBI and standard electrodes. Chronic in vivo epidural implantation of the SCBI electrodes confirmed excellent long-term recording properties in comparison to standard EEG metal electrodes. Tissue biocompatibility was demonstrated by neuropathological evaluation of the brain tissue 2 months after the implantation of the devices in the subarachnoid space. CONCLUSION: We confirm the biocompatibility of novel SCBI-based stretchable electrode devices and demonstrate their suitability for recording electrical brain activity in pre-clinical settings.

Genomic Characterization of Phenylalanine Ammonia Lyase Gene in Buckwheat.

Phenylalanine Ammonia Lyase (PAL) gene which plays a key role in bio-synthesis of medicinally important compounds, Rutin/quercetin was sequence characterized for its efficient genomics application. These compounds possessing anti-diabetic and anti-cancer properties and are predominantly produced by Fagopyrum spp. In the present study, PAL gene was sequenced from three Fagopyrum spp. (F. tataricum, F. esculentum and F. dibotrys) and showed the presence of three SNPs and four insertion/deletions at intra and inter specific level. Among them, the potential SNP (position 949th bp G>C) with Parsimony Informative Site was selected and successfully utilised to individuate the zygosity/allelic variation of 16 F. tataricum varieties. Insertion mutations were identified in coding region, which resulted the change of a stretch of 39 amino acids on the putative protein. Our Study revealed that autogamous species (F. tataricum) has lower frequency of observed SNPs as compared to allogamous species (F. dibotrys and F. esculentum). The identified SNPs in F. tataricum didn't result to amino acid change, while in other two species it caused both conservative and non-conservative variations. Consistent pattern of SNPs across the species revealed their phylogenetic importance. We found two groups of F. tataricum and one of them was closely related with F. dibotrys. Sequence characterization information of PAL gene reported in present investigation can be utilized in genetic improvement of buckwheat in reference to its medicinal value.