Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385201. As a result the site may contain information on medical devices and other products or uses of those products that are not approved in your country or region. Patients receiving HF10 therapy did not report paresthesia or uncomfortable stimulation at three months. As a result, the site may contain information on medical devices and other products or uses of those products that are not approved in other countries or regions. Some countries will require it to gather additional clinical data before granting broader coverage and reimbursement for its products. The superiority of HF10 therapy for achieving remitter status for back pain was maintained through the 24-month follow-up period of the study.
As a result, the site may contain information on medical devices and other products or uses of those products that are not approved in other countries or regions. The amendment also extends the term of the agreement to December 31, 2019, with an additional two-year automatic renewal period unless the company or EaglePicher provide notice of intent not to renew prior to the commencement of such renewal term. Published 09 2016 3. Paresthesia free pain relief for patients: HF10 therapy offers the notable benefit to patients of achieving significant and sustained pain relief without paresthesia, thus enabling its patients to avoid the uncomfortable shocking or jolting sensations commonly associated with paresthesia, and removing a major barrier for many patients who may otherwise benefit from SCS therapy. In the future, the company may need to engage in litigation to enforce patents issued or licensed to it, to protect its trade secrets or know-how, to defend against claims of infringement of the rights of others or to determine the scope and validity of the proprietary rights of others. The company also rely upon trade secrets, know-how and continuing technological innovation, and may rely upon licensing opportunities in the future, to develop and maintain its competitive position.
Below are three areas where preliminary results have been promising: Chronic neck pain with or without upper limb pain is prevalent in 48% of women and 38% of men in the general adult population, with persistent complaints in 22% of women and 16% of men. The initial term of its supply agreement with EaglePicher expired in November 2010, and the term had been automatically renewing for successive one-year periods. As a result, the coverage determination process is often a time-consuming and costly process that will require it to provide scientific and clinical support for the use of its products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained, or maintained if obtained. Outside the United States, reimbursement levels vary significantly by country, and by region within some countries. The company utilize sales agents and independent distributors to sell in an additional seven countries. On November 15, 2016, the company entered into a new multi-year supply agreement with CCC, pursuant to which CCC agreed to a revised arrangement with regard to the manufacture and supply of its IPGs. The company expect to continue to scale its manufacturing operations as the company expand Senza sales volumes in the United States. It is its intent to complete the requisite clinical studies and obtain coverage and reimbursement approval beyond what Nevro has today in countries where it makes economic sense to do so. In addition to pain reduction and reduced disability, a reduction in opioid use was observed with 90% of the patients using opioids at the start of the study compared to 12% at the end of the study. For example, over the past two years, Abbott Laboratories received FDA approval for a SCS system that offers an alternate low frequency waveform called BurstDR, and in February 2016, the company gained approval for a neuromodulation system that stimulates the dorsal root ganglion for treatment of focal pain and complex regional pain syndrome, in each case, using pivotal clinical studies for each therapy to support the FDA approval process. j��ݸ��YbW'Gc��Ҕ4�K�L������:���qqY��J��pJ��F�;]����9�J�������O�F���[ 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. Following permanent device implant, the IPG will be "activated" and thus, stimulation delivered on an ongoing basis for 12 months. Disability as measured by Oswestry Disability Index (ODI) improved by an average of 15 points at 24 months, a clinically and statistically significant improvement. In contrast to traditional SCS therapy, the company believe HF10 therapy is positioned to expand the existing SCS market by effectively treating back pain in addition to leg pain. Medtronic plc (Medtronic) has released a survey showing that 71% of patients find paresthesia uncomfortable at times. Nevro is obligated to purchase from Vention specified minimum purchase quantities of IPGs for the duration of the Vention agreement.
Pain is complex. Patient Global Impression of Change, Clinician Global Impression of Change and subject satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation. This mapping process requires a patient to be sedated for the lead placement, then awakened and repeatedly questioned in order for the physician to assess paresthesia coverage over the patient’s area of pain and reposition and reprogram the leads to redirect the paresthesia. (Clinical Trial), Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pain, 18 Years and older (Adult, Older Adult), Redwood City, California, United States, 94065, The proportion of subjects who respond to Senza SCS therapy (as assessed by VAS) for upper limb or neck pain [ Time Frame: 3 months ], Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain, Considering daily activity and rest, have average upper limb and/or neck pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment, Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician, Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device, Be 18 years of age or older at the time of enrollment, Be willing and capable of giving informed consent, Be willing and able to comply with study-related requirements, procedures, and visits. In January 2018, the company received FDA approval for its next generation Senza IITM SCS system. The results from this study led to the initiation of the SENZA-PDN RCT which will compare HF10 therapy to conventional medical management for patients suffering from painful diabetic neuropathy. The company's SENZA-RCT study, along with its European studies, represents what the company believe is the most robust body of clinical evidence for any SCS therapy. The company also have an exclusive license from the Mayo Foundation to two U.S. issued patents and one U.S. pending patent application. There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry. Research and development (R&D) expenses were $21.4 million, $33.7 million and $37.6 million, for the years ended December 31, 2015, 2016 and 2017, respectively. Existing Treatments for Chronic Pain and Limitations. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator, Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator, Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist, Have a current diagnosis of a progressive neurological disease as determined by the Investigator, Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus, Have a condition that the Investigator determines would significantly increase perioperative risk, Any previous history of surgery on the posterior elements (laminectomy, posterior fusion), Be benefitting within from an interventional procedure and/or surgery to treat upper limb pain (Subjects should be enrolled at least 30 days from last benefit), Have an existing drug pump and/or another active implantable device such as a pacemaker, Have a condition currently requiring or likely to require the use of MRI or diathermy, Have metastatic malignant disease or active local malignant disease, Have a life expectancy of less than 1 year, Have an active systemic or local infection, Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal), Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs), Be concomitantly participating in another clinical study, Be involved in an injury claim under current litigation -. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site.
The company's supply agreement is scheduled to expire in July 2019, unless terminated earlier. The company expect its competitors to launch new products and release additional clinical evidence within the next few years. Nalu Medical, Inc. (Nalu Medical) and Neuspera Medical Inc. (Neuspera Medical) are also pursuing a similar approach as well. The study enrolled 241 patients across 11 US clinical trial sites (171 patients received SCS implants at 10 sites), making it the largest prospective randomised SCS study ever conducted to assess the treatment of chronic back and leg pain. Statistical analysis also demonstrates the superior efficacy of HF10 therapy over traditional SCS therapy for all primary and secondary endpoints.
The agreement continues for ten years unless terminated earlier. Further, Nevro has commercially launched its surgical leads, marketed as the Surpass surgical lead, which the company believe will give access to approximately 30% of the U.S. SCS market that the company previously did not address fully without the surgical lead. Discover how Nevro gives you more evidence, more programming versatility, and more patient support to help your patients get back to what they love. In September 2017, the company entered into a first amendment to the Manufacturing and Supply Agreement with Vention, which changed the unit costs of the products supplied by Vention. The multicenter study compared the safety and effectiveness of HF10 therapy to traditional SCS therapy. Paresthesia is often considered unpleasant or uncomfortable, sometimes causes a shocking or jolting sensation with changes in posture and is a continuous reminder of the patient’s chronic condition.