As such, innovation in the SCS market has historically focused on technologies that optimize traditional SCS therapy’s ability to create more precise paresthesia fields. The company also face competition to recruit and retain qualified sales and other personnel. The company began its direct sales operations in the United Kingdom in late 2010 and to date have expanded its direct sales operations to Austria, Australia, Belgium, Germany, Luxembourg, Norway, Sweden and Switzerland. The company believe the clinical results from its SENZA-RCT study, along with its European studies, position it with superior and compelling efficacy data. Every person is unique and your medical needs differ from those of others, even people with the same condition and the same SCS system. j��ݸ��YbW'Gc��Ҕ4�K�L������:���qqY��J��pJ��F�;]����9�J�������O�F���[ The company endeavor to maintain executive and organization liability insurance in a form and with aggregate coverage limits that the company believe are adequate for its business purposes, but its coverage limits may prove not to be adequate in some circumstances. The following charts provide a comparison of HF10 therapy in both pain reduction and responder rates against the other prospective Level 1 studies conducted. To complement its sales representatives, the company intend for its marketing and reimbursement teams to drive HF10 therapy adoption through creating awareness and demand among additional stakeholders involved in the SCS treatment decision, including third-party payors, hospital administrators, and patients and their families. Two-thirds of HF10 therapy patients had a VAS pain score of less than or equal to 2.5 on a scale of 0 to 10 for back pain at three months (which the company define as achieving remitter status), which is nearly twice the number of traditional SCS therapy patients (35%) with a VAS pain score of less than or equal to 2.5, results that were statistically superior. 3652 0 obj <>/Filter/FlateDecode/ID[<89099516404890469BC774E34E2DC978><0AA089BA5D17D347AF26E2345D1BD3E1>]/Index[3632 32]/Info 3631 0 R/Length 103/Prev 792322/Root 3633 0 R/Size 3664/Type/XRef/W[1 3 1]>>stream Study subjects will be identified from the pool of candidates for SCS therapy affiliated with, or referred to, the clinical sites. Traditional SCS products have required paresthesia to provide pain relief, and consequently, paresthesia coverage has been used as a surrogate metric for successful pain relief. Nevro is required to demonstrate continuing compliance with applicable regulatory requirements to maintain these certifications and will continue to be periodically inspected by international regulatory authorities for certification purposes. The charger is mobile and can be worn around the waist using a belt when charging is needed, so that the patient can perform various tasks while charging. Safety outcomes were consistent across the treatment groups, with the exception of uncomfortable paresthesia in traditional SCS patients, which was not in HF10 therapy patients. The company believe Nevro has built competitive advantages through its proprietary technology, clinical evidence base, strong track record of execution with over 28,000 patients implanted with Senza, extensive intellectual property and a proven management team with substantial neuromodulation experience. There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. The Senza SCS system received FDA approval in May of 2015. Medicare reimbursement rates for the same or similar procedures vary due to geographic location, nature of the facility in which the procedure is performed (i.e., hospital outpatient department or outpatient surgery centers) and other factors.
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