Pavmed plans safety study for CarpX following FDA meeting

After a meeting with the FDA, Pavmed (NSDQ:PAVM) said that the agency wants to see more clinical testing for the CarpX device before it can make a decision on whether or not to approve the product. In August last year, the FDA group reviewing Pavmed’s 510(k) application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The hangup, according to an SEC filing, is that the group is “focused on protection of important structures during the procedure. [The FDA] recommended clinical testing to definitively document procedural safety in humans and provided initial guidance on parameters for this testing.” The FDA reportedly told Pavmed that a well-designed study outside of the U.S. would be sufficient to prove that CarpX, a minimally-invasive device designed to treat carpal tunnel syndrome, is safe. The company also announced that it expects to submit CarpX for CE Mark clearance in the European Union by the end of this quarter. “I am very pleased with how this week’s pre-submission meeting and follow-up interactions with the FDA have gone,” chairman &CEO Dr. Lishan Aklog said in prepared remarks. “The goal of the pre-submission process is to receive clear and definitive guidance on what the company needs to do to demonstrate substantial equivalence. I am grateful that the FDA personnel showed up in force, despite the government shutdo...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Featured Food & Drug Administration (FDA) Wall Street Beat Pavmed Source Type: news

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We report the clinical features of a patient with hereditary ATTR amyloidosis associated with a novel mutation (Y114S, p.Y134S). A 65-year-old Japanese man was admitted to our hospital after a 3-year history of progressive dyspnea on exertion. Five years previously, he presented dysesthesia in both hands caused by carpal tunnel syndrome. A genetic analysis revealed a base pair substitution of adenine to cytosine in the second codon of exon 4, residue 114, in the TTR gene (c.401A>C). The clinical characteristics were progressive cardiomyopathy with a poor vital prognosis, late onset, sporadic case, bilateral carpal tunne...
Source: Internal Medicine - Category: Internal Medicine Tags: Intern Med Source Type: research
In this study, the authors compared ultrasonography with neurophysiological findings for the diagnosis of CTS in 96 patients/hands with clinical symptoms of CTS. The latency, amplitude, distance, and velocity of the median and ulnar nerves were measured. Needle electromyography was performed in the abductor pollicis brevis, in addition to muscles of the arm and forearm, to exclude proximal median nerve, brachial plexus, or radicular abnormalities. Ultrasonography was based on the morphologic/anatomic changes of the median nerve cross-sectional area in the sagittal plane of the wrist at the level of the pisiform bone, the c...
Source: Orthopedics - Category: Orthopaedics Authors: Tags: Orthopedics Source Type: research
This report details the variation, compares it with other reported variations, presents the related embryology, and reviews the significance of this variation as it relates to inflammatory conditions and surgical procedures. PMID: 31169299 [PubMed - as supplied by publisher]
Source: Folia Morphologica - Category: Anatomy Tags: Folia Morphol (Warsz) Source Type: research
Authors: Latten S, Andreisek G, Ganser J PMID: 31167283 [PubMed - in process]
Source: Handchirurgie Mikrochirurgie Plastische Chirurgie - Category: Cosmetic Surgery Tags: Handchir Mikrochir Plast Chir Source Type: research
To produce an electronic decision tree (DT) version of the Boston Carpal Tunnel Questionnaire (DT-BCTQ) using the Chi-squared automatic interaction detection (CHAID) algorithm to reduce questionnaire length of the Boston carpal tunnel questionnaire (BCTQ) while minimizing the loss of measurement properties.
Source: Archives of Physical Medicine and Rehabilitation - Category: Rehabilitation Authors: Source Type: research
Conclusions Excess body mass and occupational physical factors increase the risk of hospitalization for CTS. Excess body mass potentiates the adverse effects of strenuous work on CTS.byHulkkonen S, Shiri R, Auvinen J, Miettunen J, Karppinen J, Ryh änen J. doi:10.5271/sjweh.3836
Source: Scandinavian Journal of Work, Environment and Health - Category: Occupational Health Tags: Original article Source Type: research
Conclusions Excess body mass and occupational physical factors increase the risk of hospitalization for CTS. Excess body mass potentiates the adverse effects of strenuous work on CTS. PMID: 31168633 [PubMed - as supplied by publisher]
Source: Scandinavian Journal of Work, Environment and Health - Category: Occupational Health Authors: Tags: Scand J Work Environ Health Source Type: research
Peripheral neuropathy (often defined as weakness of sensory loss in one limb) of the upper extremity is a common clinical musculoskeletal scenario. The most common include carpal tunnel syndrome, cubital tunnel syndrome, and cervical radiculopathy. A combination of clinical examination, electrodiagnostic testing, and imaging studies, chiefly MR imaging and ultrasonography, is often needed to identify a specific diagnosis for an individual patient. In many cases, ultrasonography is preferred because of ease of access, the possibility of quick contralateral extremity imaging for comparison, and lower cost profile. MR imaging...
Source: Radiologic Clinics of North America - Category: Radiology Authors: Source Type: research
This study aimed to compare the efficacy and safety of wrist arthroscopy, small incision surgery, and conventional open carpal tunnel release surgery for the treatment of carpal tunnel syndrome. MATERIAL AND METHODS Patients with carpal tunnel syndrome (n=111) were treated with wrist arthroscopy (n=33), small incision surgery (n=40), and conventional open carpal tunnel release surgery (n=38). Incision length, duration of surgery, degree of intraoperative bleeding, recovery time, and findings at postoperative follow-up at one month, three months, and six months after surgery were recorded. Assessment included the two-point ...
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
Abstract Carpal tunnel syndrome is a very common condition in hand surgery. The gold standard in therapy is the surgical release of the flexor retinaculum. Endoscopic carpal tunnel release provides superior convalescence and patient safety. In this video paper, we demonstrate endoscopic carpal tunnel release via a monoportal approach and report our experience in treating over 800 cases. PMID: 31167264 [PubMed - in process]
Source: Zentralblatt fur Chirurgie - Category: Surgery Authors: Tags: Zentralbl Chir Source Type: research
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