ASIS for Botox in Upper Limb Spasticity

Summary

Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.

Timeline

Start

2016-01

Primary completion

2016-06

Completion

2017-06

Publications

• Background Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA. A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629.
• Background Knopp MV, Balzer T, Esser M, Kashanian FK, Paul P, Niendorf HP. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol. 2006 Jun;41(6):491-9. doi: 10.1097/01.rli.0000209657.16115.42.
• Background Turner-Stokes L, Ward A. Botulinum toxin in the management of spasticity in adults. Clin Med (Lond). 2002 Mar-Apr;2(2):128-30. doi: 10.7861/clinmedicine.2-2-128.
• Background Patrick E, Ada L. The Tardieu Scale differentiates contracture from spasticity whereas the Ashworth Scale is confounded by it. Clin Rehabil. 2006 Feb;20(2):173-82. doi: 10.1191/0269215506cr922oa.
• Background Jost WH, Hefter H, Reissig A, Kollewe K, Wissel J. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. J Neurol Sci. 2014 Feb 15;337(1-2):86-90. doi: 10.1016/j.jns.2013.11.022. Epub 2013 Nov 22.
• Background Baker JA, Pereira G. The efficacy of Botulinum Toxin A for spasticity and pain in adults: a systematic review and meta-analysis using the Grades of Recommendation, Assessment, Development and Evaluation approach. Clin Rehabil. 2013 Dec;27(12):1084-96. doi: 10.1177/0269215513491274. Epub 2013 Jul 17.
• Background Ghasemi M, Salari M, Khorvash F, Shaygannejad V. A literature review on the efficacy and safety of botulinum toxin: an injection in post-stroke spasticity. Int J Prev Med. 2013 May;4(Suppl 2):S147-58.

Drugs

Indications