Tx360EU INTENDED USE
The Tx360EU Nasal Applicator device is intended to deliver fluids, selected by a healthcare professional, to the mucous membrane covering structures of the nasal pathway, such as the inferior turbinate, middle turbinate, superior turbinate, sphenopalatine foramen, nasal septum, etc. The Tx360EU provides an aid to physicians in the delivery of drugs used as nerve block agents when performing sphenopalatine ganglion nerve block for the purpose of treating headaches.
Dr. Tian Xia, is the sole owner of the company, had invented Tx360® device. It is currently available for sale in United States(Tx360®), and European Union Tx360EU).
Tian Medical is located in Grayslake IL. The company is primarily engaged in venture funding, research and development of biotechnology and life sciences.
Tian Medical had developed the Tx360® and Tx360EU Nasal Applicator.
Tx360® / Tx360EU medical device is the one and only product of its kind commercially available for sale in United States(Tx360®) and European Union(Tx360EU) for use by medical professionals.
The Tx360EU Nasal Applicator was developed by a biotech research and development company in the United States. This medical device is currently being manufactured in Grayslake, Illinois, USA.
Tx360EU nasal applicator has a soft needle extension that allows the anesthetic agent to be delivered directly on to the sphenopalatine foramen. The result is instant headache relief, expected from a nerve block. The treatment takes less than 30 seconds, and most patients report pain reduction within a few minutes.
Because the SPG is located deep in the nasal cavity, a normal nasal spray cannot reach the desired location. Unlike other nasal sprays, the revolutionary, Tx360EU nasal applicator is designed to be gently inserted into a patient’s nose, as they sit, and deliver medication precisely and consistently to the area of the SPG.
The Tx360EU is not a headache treatment per se, it is a medication delivery device that transforms a SPGB into a quick, simple, comfortable procedure. As a result, practitioner can safely and efficiently perform the SPGNB as frequently as necessary for the purpose of restoring the normal physiologic function of the parasympathetic outflow in the cranial region – resolution of your headaches.
Warnings and Precautions
The Tx360EU Nasal Applicator should be used with care only by trained healthcare professionals. Complications may include:
Do not use the Tx360EU Nasal Applicator in the following conditions (contraindications):
Do not use the Tx360EU Nasal Applicator if:
Discard appropriately after use.
Reuse of the Tx360EU Nasal Applicator may cause serious infections and introduction of bacteria, such as VRE (Vancomycin-Resistant Enterococcus) or MRSA (Methicillin-Resistant Staphylococcus Aureus).
What is SPG Block (Sphenopalatine Ganglion Block) and why should I consider it for my patient?
The sphenopalatine ganglion (SPG) is located just deep to the nasal mucosa posterior to the middle nasal turbinate. The SPG can be blocked by diffusion of local anesthetic through the overlying mucosa. Sensory, sympathetic and parasympathetic fibers pass through or synapse in the SPG, making it a key structure in various types of cephalgia. Temporarily blocking function of the SPG can provide prompt, and sometimes sustained, relief of pain. It is theorized that SPGB provides sustained relief by disrupting dysfunctional neuronal activity, allowing restoration of normal function.
Getting serious about blocking headache pain.
Currently there is very little to offer the chronic migraine headache patient. Nearly two thirds of patients discontinue prescription medications due to inadequate relief and side-effects.
SPG blocks achieve neuromodulation of the sphenopalatine ganglion complex. This means that the time-tested efficacy of the procedure has been shown to have both immediate and sustained results. These effects are typically sustained by interrupting the chaotic signaling associated with migraine.
Although proven effective, few physicians offer the SPG block to patients because the traditional procedures are uncomfortable and dangerous for the patient and demanding for the care giver. Traditionally, the block is attempted by navigating a cotton tip applicator through the nasal passages and place it there for 30 minutes, or with a long needle through the side of the head. These approaches carry risks and sometimes require sedation.
Today, establishing an SPG block has never been easier. The patented Tx360EU offers the practitioner the ability to offer a first-line treatment in the chronic headache patient. Tx360EU delivers medication that can sustain pain relief in a ten to thirty seconds procedure that is comfortable and quick. With Tx360EU, SPG may be achieved without needles, cotton swabs, atomizer sprays or systemic narcotics.
SPG blocks have time-tested efficacy when it comes to serious chronic and episodic migrainous pain.
SPG Blocks have been performed for centuries, but new technology allows them to be performed with comfort and ease
Tx360EU is a single-use, disposable catheter that delivers medication through the nasal passages to a difficult-to-reach ganglion located at the back of the nose easily, safely, efficiently and accurately (only 0.6cc of medication needed).
When used as indicated, Tx360EU delivers the medication immediately proximate to the ganglion to achieve a Sphenopalatine Ganglion or SPG block. Interventional radiologists, neurologists, internists, emergency departments and pain specialists are interested in utilizing Tx360EU for a safe, comfortable and quick delivery of the medication required for the SPG block procedure.
The drug delivery innovation, Tx360EU, is drawing the attention of physicians who treat patients with chronic and episodic migraine, cluster headache, and chronic daily headache and for other applications. The SPG blocks have been studied for many disorders for over a century. More recently however, the block has been associated with profound neuromodulation of the SPG complex, resetting the chaotic signaling associated with chronic migraine with both immediate and sustained results.
Though widely accepted as effective, few physicians are willing to perform an SPG block because the traditional procedures are uncomfortable for the patient and demanding for the caregiver. Formerly, the block was attempted by navigating a cotton tip applicator through the nasal passages, by atomizing a spray or with a long needle through the side of the head. These older approaches carry risks, sometimes require sedation and may not be effective in all patients.
Headache alone affects nearly 45 million individuals, and migraine occurs in 6.8% of men and 15-18% of women. Nearly two-thirds of headache patients discontinue prescription medications due to inadequate relief and side effects. The SPG block may also have utility in the treatment of other disorders. Tx360EU is designed to deliver medicines right onto the sphenopalatine foreman in order to block the entire SPG apparatus. Tx360EU allows easy and accurate placement of medications right onto the sphenopalatine foramen, no imaging guidance is necessary.
A Novel Revision to the Classical Transnasal Topical Sphenopalatine Ganglion Block for the Treatment of Headache and Facial Pain
A Novel Revision to the Classical Transnasal Tropical Sphenopalatine Ganglion Block Treatment of Headache and Facial Pain has been printed by the Pain Physicians Journal: Offical Journal of the American Society of Interventional Pain Physicians.
Pain Physician 2013;16;E769-E778.
A Novel Revision to the Classical Transnasal Topical Sphenopalatine Ganglion Block for the Treatment of Headache and Facial Pain Case Series. Kenneth D. Candido, MD, Scott T Massey, MD, Ruben Sauer, MD, Raheleh Rahimi Darabad, MD, and Nebojsa Nick Knezevic, MD, PhD.
BACKGROUND: The sphenopalatine ganglion (SPG) is located with some degree of variability near the tail or posterior aspect of the middle nasal turbinate. The SPG has been implicated as a strategic target in the treatment of various headache and facial pain conditions, some of which are featured in this manuscript. Interventions for blocking the SPG range from minimally to highly invasive procedures often associated with great cost and unfavorable risk profiles.
OBJECTIVE: The purpose of this pilot study was to present a novel, FDA-cleared medication delivery device, the Tx360® nasal applicator, incorporating a transnasal needleless topical approach for SPG blocks. This study features the technical aspects of this new device and presents some limited clinical experience observed in a small series of head and face pain cases.
STUDY DESIGN: Case series.
SETTINGS: Pain management center, part of teaching-community hospital, major metropolitan city, United States.
METHODS: After Institutional Review Board (IRB) approval, the technical aspects of this technique were examined on 3 patients presenting with various head and face pain conditions including trigeminal neuralgia (TN), chronic migraine headache (CM), and post-herpetic neuralgia (PHN).
The subsequent response to treatment and quality of life was quantified using the following tools: the 11-point Numeric Rating Scale (NRS), Modified Brief Pain Inventory — short form (MBPI-sf), Patient Global Impression of Change (PGIC), and patient satisfaction surveys. The Tx360® nasal applicator was used to deliver 0.5 mL of ropivacaine 0.5% and 2 mg of dexamethasone for SPG block. Post-procedural assessments were repeated at 15 and 30 minutes, and on days one, 7, 14, and 21 with a final assessment at 28 days post-treatment. All patients were followed for one year. Individual patients received up to 10 SPG blocks, as clinically indicated, after the initial 28 days.
RESULTS: Three women, ages 43, 18, and 15, presented with a variety of headache and face pain disorders including TN, CM, and PHN. All patients reported significant pain relief within the first 15 minutes post-treatment. A high degree of pain relief was sustained throughout the 28 day follow-up period for 2 of the 3 study participants. All 3 patients reported a high degree of satisfaction with this procedure. One patient developed minimal bleeding from the nose immediately post-treatment which resolved spontaneously in less than 5 minutes. Longer term follow-up (up to one year) demonstrated that additional SPG blocks over time provided a higher degree and longer lasting pain relief.
LIMITATIONS: Controlled double blind studies with a higher number of patients are needed to prove efficacy of this minimally invasive technique for SPG block.
CONCLUSION: SPG block with the Tx360® is a rapid, safe, easy, and reliable technique to accurately deliver topical transnasal analgesics to the area of mucosa associated with the SPG. This intervention can be delivered in as little as 10 seconds with the novice provider developing proficiency very quickly. Further investigation is certainly warranted related to technique efficacy, especially studies comparing efficacy of Tx360 and standard cotton swab techniques.
Roger Cady, MD 1 • Joel Saper, Md2 • Ryan Cady, MS1 • Heather Manley, MS1 • Jeanne Tarrasch, RN/BSN1 • Alice Oh, LPN1
1-Headache Care Center, Springfield, MO; 2-Michigan Head Pain & Neurological Institute, Ann Arbor, MI
BACKGROUND: The Sphenopalatine Ganglion (SPG) is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa (PPF) in close proximity to the sphenopalatine foramen. The SPG is innervated by the maxillary division of the trigeminal nerve and has a sensory, parasympathetic, and sympathetic component. It has been implicated in several orofacial pain conditions including migraine. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. Blocking the SPG using local anesthetics may relieve pain associated with chronic migraine.
The purpose of this study is to evaluate the safety and efficacy of 0.5% bupivacaine sphenopalatine ganglion blockades for the treatment of chronic migraine delivered via the Tx360® device. This device contains a small, flexible, soft plastic tube that is advanced below the middle turbinate just past the pterygopalatine fossa. The plastic tube can then be rotated laterally on a preset track and extended into the intranasal space. A total of 0.3 cc of anesthetic (0.5% bupivacaine) is injected through the tube and directed to the mucosa covering the SPG. The procedure is performed similarly in each nostril.
OBJECTIVES: This pilot study aimed to evaluate the Tx360® device through the review of patient reported outcomes in a chronic migraine population.
To compare the impact of pain questions before treatment and 24 hours post treatment using the Tx360® device with 0.5% bupivacaine vs. saline.
Compare the change in Headache Impact Test (HIT-6) scores from baseline to end of treatment for bupivacaine vs. saline.
Patient satisfaction with treatment for bupivacaine vs. saline.
Fifty-five subjects were screened for this study, meeting the proposed sample size of 42 subjects. The study population consisted of 41 subjects randomized per protocol. Subjects included 10 males and 31 females between the ages of 18-67 and a mean age of 41.30 with a diagnosis of ICHD-II definition of chronic migraine. The average length of chronic migraine diagnosis was 8.58 years. Subjects, on average, experienced 15.24 migraines and 23.63 headaches in a month during baseline. Of the randomized population, 34 were Caucasian, 4 were African American, and 3 Other. Forty subjects completed treatment, although 3 subjects had protocol violations and were therefore removed from the study. A total of 38 subjects were analyzed; 26 subjects treated with bupivacaine and 12 with saline.
METHODS: This was a 2 center, randomized, double-blind, placebo controlled study consisting of 55 screened subjects, 18 to 67 years of age, meeting the definition of chronic migraine. Subjects were asked to complete a daily baseline headache diary for 28 days. Following the baseline period, subjects meeting the diagnostic criteria for chronic migraine per diary analysis were randomized 2:1 receiving either 0.3 cc of 0.5% bupivacaine or saline delivered to the mucosal surface of the SPG though each nares with the Tx360® device. The procedure was repeated twice weekly for 6 weeks. Subjects continued to complete a daily headache diary throughout the treatment period and 1 month post treatment. Also during the treatment period, subjects completed a battery of questionnaires 15 and 30 minutes post treatment, as well as 24 hours post treatment.
Subjects Treating with Bupivacaine Experienced Significant Reductions in Pain Levels 24 Hours Post Treatment
Subjects in the bupivacaine group reported significantly lower levels of pain 24 hours after treatment (measured by greatest level of pain, least level of pain, average pain and percent relief). There was no significant change reported by subjects receiving saline as a sham treatment.
Mood, Work, Relationship, and Sleep Interference Ratings Significantly Decreased for Subjects Treating With Bupivacaine
The bupivacaine group also reported a significantly improved ability to accomplish normal work related tasks (p = .004) and improved sleep (p < .001). The saline group showed increased impairment in their mood (p =.03) and relationships with others (p =.01). When looking at between group differences, all quality of life measurements, including general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life, were significantly different between the bupivacaine and saline groups (p < .001).
HIT-6 Scores Significantly Decreased Following 6 Weeks of Treatment in Subjects Treating with Bupivacaine
HIT-6 scores significantly decreased in the bupivacaine group (-4.75, p = .005) from baseline to the end of the treatment period (6 weeks) while again there was no significant change for the saline group (-1.55 p = .09). Average treatment satisfaction scores at the end of the treatment period (6 weeks) were significantly higher for Group A compared with Group B. (3.50 vs. 2.91, p < .001).
Satisfaction Scores Were Significantly Higher for the Bupivacaine Group Compared to the Saline Group
CONCLUSION: Repetitive SPG blocks utilizing 0.5% bupivacaine delivered by through a Tx360® device significantly reduced pain associated with chronic migraine. Furthermore, subjects reported better sleep and increased function at work over the 6 week time of the study. Additionally, subjects receiving the active treatment had significant improvement in HIT-6 scores at the end of the treatment period vs. baseline. These results suggest that repetitive SPG blockade with 0.5% bupivacaine administered with the Tx360® device may be an efficacious treatment and improve clinical outcomes for patients with chronic migraine.
S22 2014 SAEM Abstract
Jason T Schaffer, Kevin Ball, Benton Hunter, and Christopher Weaver
Indiana University, Indianapolis, IN
BACKGROUND: Acute headache is a common chief complaint in patients presenting to the ED. Sphenopalatine ganglion (SPG) anesthesia has been described for the treatment of cluster headache but no prospective studies exist for its use in undifferentiated acute headache.
OBJECTIVES: To assess the effectiveness of SPG anesthesia in treating acute anterior headache in the ED using a noninvasive approach with the Tx360 device. We hypothesized a 30% improvement in number of patients achieving 50% reduction in pain by VAS at 15 minutes with bupivacaine as compared to placebo.
METHODS: Randomized double-blinded placebo-controlled trial of bupivacaine anesthesia of the SPG using the Tx360 device (Figure 42). ED patients with anterior focused or global acute headache were identiﬁed. Study sample size was calculated (n=84) for 80% power to detect a difference between groups for the primary endpoint of 50% reduction in pain by VAS. Bupivacaine or normal saline (NS) were delivered (0.3ml per each nare) using the Tx360 device. The Tx360 is a catheter device that directionally sprays the medication intranasally onto the mucosal surface over the SPG. Pain and nausea were measured at time=0, 5, and 15 minutes by a 100mm VAS. Phonecall follow-up assessed secondary endpoints of 24-hour pain and nausea.
RESULTS: The mean reported baseline VAS for pain in the bupivacaine group was 77.2 ±18.2 and 76.7 ±18.1 in the NS group. At 15 minutes the mean reported VAS for pain in the bupivacaine group was 39 ±34.5 and 47.6 ±35.1 in the NS group (p=0.289). A 50% reduction in pain was achieved in 50% (20/40 patients) of the bupivacaine group vs. 40.4% (19/ 47 patients) in the NS group (p=0.311). There were no adverse side effects reported in either group. At 24 hours there was a signiﬁcant difference in report of headache (29% vs. 54%, p=0.037) and nausea (3.4% vs. 28%, p=0.009) favoring the bupivacaine group.
CONCLUSION: For treatment of acute headache with SPG anesthesia vs placebo, there was no difference at 15 minutes for SPG anesthesia. At 24 hours, we found a statistically signiﬁcant beneﬁt for the anesthesia group versus the placebo group.
OBJECTIVES: Compare Modified Brief Pain Inventory Scores before treatment and 24 hours post treatment for TX360 with 0.5% bupivacaine (Group A) vs. saline (Group B)
Compare baseline and post treatment HIT-6 scores for Group A vs. Group B
Compare patient satisfaction with treatment for Group A vs. Group B
BACKGROUND: The sphenopalatine ganglion (SPG) is a small heart shaped structure that resides within the pterygopalatine fossa in close proximity to the sphenopalatine foramen. It has been implicated in several orofacial pain conditions including migraine. It is largely innervated by the maxillary nerve. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. Blocking the SPG using local anesthetics may relieve pain associated with chronic migraine. Unfortunately, many current interventions are cumbersome, invasive, and expensive. Some are associated with significant and sometimes serious adverse events. The purpose of this study is to evaluate the efficacy and usability of the Tx360, a new nasal applicator device, utilizing 0.5% bupivacaine vs. saline in the treatment of chronic migraine.
METHODS: This was a 2 center, randomized, double-blind, placebo controlled study consisting of 55 screened subjects, 18 to 65 years of age, meeting the ICHD-11 appendix definition of chronic migraine. Subjects were asked to complete a daily baseline headache diary for 28 days. Following the baseline period, 41 subjects met diagnostic criteria for per diary analysis and were randomized 2:1 receiving either 0.3 ml of O.5% bupivacaine or saline delivered to the mucosal surface of the SPG though each nares with the Tx360 device. The procedure was repeated twice weekly for 6 weeks.
RESULTS: Subjects in Group A reported significantly lower levels of pain 24 hours after treatment (measured by greatest level of pain, least level of pain, average pain and percent relief). There was no significant change reported by subjects receiving saline as a sham treatment. Group A also reported a significantly improved ability to accomplish normal work related tasks and improved sleep. There was no change in these activities for Group B. HIT -6 scores significantly decreased in Group A, the active treatment group (-4.75, p < 0.01) from baseline to after the last treatment (6 weeks) while again there was no significant change for group B (-1.55 p =0.09). Average treatment satisfaction scores at the end of the treatment period (6 weeks) were significantly higher for Group A compared with Group B. (3.50 vs. 2.91, p < 0.001).
CONCLUSIONS: Repetitive SPG blocks utilizing 0.5% bupivacaine delivered by through a TX360 device significantly reduced pain associated with chronic migraine. Further subjects reported better sleep and increased function at work over the 6 week time of the study. Additionally subjects receiving the active treatment had significant improvement in HIT-6 scores at the end of the treatment period vs. baseline. These results suggest that repetitive SPG blockade with 0.5% bupivacaine administered with the TX360 device may be an efficacious treatment and improve clinical outcomes for patients with chronic migraine.
OBJECTIVES: Compare Numeric Rating Scale (NRS) score between active and sham treatment groups.
Compare the number of headache days between active and sham treatment groups
Compare 24-hour after procedure Patient’s Global Impression of Change (PGIC) score for between active and sham treatments groups.
Compare acute medications usage between active and sham treatment groups.
Compare the adverse events of subjects receiving SPG block with bupivacaine vs. saline.
BACKGROUND: The sphenopalatine ganglion (SPG) is a small heart shaped structure that resides deep within the pterygopalatine fossa in close proximity to the sphenopalatine foramen and is implicated in orofacial pain conditions including migraine. It is largely innervated by the maxillary nerve. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. Blocking the SPG using local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome, invasive, expensive and some associated with significant adverse events. The purpose of this study is to evaluate the efficacy and usability of the Tx360, a new nasal applicator device, in the treatment of migraine.
METHODS:This was a 2 center, randomized, double-blind, placebo controlled study consisting of 55 screened subjects, 18 to 65 years of age, meeting the ICHD-11 appendix definition of chronic migraine. Subjects were asked to complete a daily baseline headache diary for 28 days. Following the baseline period, 41 subjects met diagnostic criteria for chronic migraine per diary analysis and were randomized 2: 1 receiving either 0.3 mL of 0.5% bupivacaine or saline delivered to the mucosal surface of the SPG though each nares with the Tx360® device. The procedure was repeated twice weekly for 6 weeks.
RESULTS:There was a reduction in the NRS in subjects receiving the active treatment compared to the sham procedure at 15 min (3.51 vs 2.53, p<0.0001), 30 min (3.45 vs 2.41, p < 0,0001), and 24 hours post treatment (4.20 vs 2.85, p < 0.001). Subjects in the treatment group had a reduction in the number of headache days per month from baseline to the end of treatment period while the sham group did not (-3.58 days vs. -0.75 days, p < 0.01). Furthermore subjects receiving active treatment had significant decreases in Patients Global Impression of Change compared to the sham treatment group at 30 min (3.72 vs. 3.00, p < 0.001) and 24 hours (3.88 vs 3.08, p < 0.001) post treatment. Total acute medication usage was similar between the two groups. However, the average usage of opioids per subject during the treatment phase was lower in the treatment group compared to the sham group (8.33 vs. 45.7). No serious adverse events were reported and there was no difference in non-serious adverse events between groups.
CONCLUSIONS: SPG blocks using the TX360 device provide rapid and sustained migraine relief for a population of patients with chronic migraine. Importantly, subjects in the treatment group experienced a significant reduction in headache days during the treatment. This study provides evidence for the effectiveness and tolerability of treating chronic migraine with the TX360 device.