Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts

paythelady.61 shared this article with you from Inoreader Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts Via Latest Results for Journal of Cardiovascular Translational Research Abstract Successful translation of new and innovative medical products from concept to clinical use is a complex endeavor that requires understanding and overcoming a variety of challenges. In particular, regulatory pathways and processes are often unfamiliar to academic researchers and start-ups, and even larger companies. Growing evidence suggests that the successful translation of ideas to products requires collaboration and cooperation between clinicians, researchers, industry, and regulators. A multi-stakeholder group developed this review to enhance regulatory knowledge and thereby improve translational success for medical devices. Communication between and among stakeholders is identified as a critical factor. Current regulatory programs and processes to facilitate communication and translation of innovative devices are described and discussed. Case studies are used to highlight the importance of flexibility when considering evidence requirements. We provide a revi ew of emerging strategies, opportunities, and best practices to increase the regulatory knowledge base and facilitate medical device translation by all stakeholders. Graphical abstract Clinicians, regulators, industry, and researchers require regulatory knowledge and collaboration for successful translation of innovative medical devices View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

18F-FDG-PET/CT can be used to predict distant metastasis in hypopharyngeal squamous cell carcinoma

paythelady.61 shared this article with you from Inoreader 18F-FDG-PET/CT can be used to predict distant metastasis in hypopharyngeal squamous cell carcinoma Via Most Recent Articles: Journal of Otolaryngology - Head & Neck Surgery Hypopharyngeal squamous cell carcinoma (HPSCC) has a high rate of distant metastasis, resulting in poor prognosis. The role of the maximum standardized uptake value (SUVmax), which was assessed via pretreatmen... View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

In Vivo Murine Models of Cardiotoxicity Due to Anticancer Drugs: Challenges and Opportunities for Clinical Translation

paythelady.61 shared this article with you from Inoreader In Vivo Murine Models of Cardiotoxicity Due to Anticancer Drugs: Challenges and Opportunities for Clinical Translation Via Latest Results for Journal of Cardiovascular Translational Research Abstract Modern therapeutic approaches have led to an improvement in the chances of surviving a diagnosis of cancer. However, this may come with side effects, with patients experiencing adverse cardiovascular events or exacerbation of underlying cardiovascular disease related to their cancer treatment. Rodent models of chemotherapy-induced cardiotoxicity are useful to define pathophysiological mechanisms of cardiac damage and to identify potential therapeutic targets. The key mechanisms involved in cardiotoxicity induced by specific different antineoplastic agents are summarized in this state-of-the-art review, as well as the rodent models of cardiotoxicity by different classes of anticancer drugs, along with the strategies tested for primary and secondary cardioprotection. Current approaches for early detection of cardiotoxicity in preclinical studies with a focus on the application of advanced imaging modalities and biomarker strategies are also discussed. Graphical abstract Potential applications of cardiotoxicity modelling in rodents are illustrated in relation to the advancements of promising research topics of cardiotoxicity. Created with BioRender.com. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Functional Impact and Regulation of Alternative Splicing in Mouse Heart Development and Disease

paythelady.61 shared this article with you from Inoreader Functional Impact and Regulation of Alternative Splicing in Mouse Heart Development and Disease Via Latest Results for Journal of Cardiovascular Translational Research Abstract Alternative splicing (AS) plays a major role in the generation of transcript diversity. In the heart, roles have been described for some AS variants, but the global impact and regulation of AS patterns are poorly understood. Here, we studied the AS profiles in heart disease, their relationship with heart development, and the regulatory mechanisms controlling AS dynamics in the mouse heart. We found that AS profiles characterized the different groups and that AS and gene expression changes affected independent genes and biological functions. Moreover, AS changes, specifically in heart disease, were associated with potential protein–protein interaction changes. While developmental transitions were mainly driven by the upregulation of MBNL1, AS changes in disease were driven by a complex regulatory network, where PTBP1 played a central role. Indeed, PTBP1 over-expression was sufficient to induce cardiac hypertrophy and diastolic dysfunction, potentially by perturb ing AS patterns. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

The Role of Angiogenesis and Arteriogenesisin Myocardial Infarction and Coronary Revascularization

paythelady.61 shared this article with you from Inoreader The Role of Angiogenesis and Arteriogenesisin Myocardial Infarction and Coronary Revascularization Via Latest Results for Journal of Cardiovascular Translational Research Abstract Surgical myocardial revascularization is associated with long-term survival benefit in patients with multivessel coronary artery disease. However, the exact biological mechanisms underlying the clinical benefits of myocardial revascularization have not been elucidated yet. Angiogenesis and arteriogenesis biologically leading to vascular collateralization are considered one of the endogenous mechanisms to preserve myocardial viability during ischemia, and the presence of coronary collateralization has been regarded as one of the predictors of long-term survival in patients with coronary artery disease (CAD). Some experimental studies and indirect clinical evidence on chronic CAD confirmed an angiogenetic response induced by myocardial revascularization and suggested that revascularization procedures could constitute an angiogenetic trigger per se. In this review, the clinical and basic science evidence regarding arteriogenesis and angiogenesis in both CAD and coro nary revascularization is analyzed with the aim to better elucidate their significance in the clinical arena and potential therapeutic use. Graphical abstract View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Analysis of Different Techniques of Tonsillectomy: An Insight

paythelady.61 shared this article with you from Inoreader Analysis of Different Techniques of Tonsillectomy: An Insight Via Latest Results for Indian Journal of Otolaryngology and Head Abstract Tonsillectomy is one of the most commonly performed surgical procedure in otolaryngology especially in children. This is an age old procedure which has seen continuous changes in the surgical technique from guillotine method to snare technique to coblation tonsillectomy, and is still evolving day by day. But there are no consensus as to which technique is the best or most appropriate for tonsillectomy. The objective of this study is to compare three different surgical techniques of tonsillectomy namely the Cold dissection snare technique (CDST), Bipolar electro-dissection technique (BEDT) and Harmonic scalpel technique (HST) and to identify the method which is safe, with less operative time, which offers decreased intra-operative blood loss and with lowest post-operative morbidity and complications. This prospective and comparative study was conducted over a time duration of 1 year 6 months from January 2018 to July 2019 after the approval from ethical committee. Total 150 cases of tonsillectomy were done by dividing into three groups of 50 cases each. The study showed maximum cases of tonsillitis in the age group less than 10 years and the most common indication for tonsillectomy being chronic recurrent tonsillitis. Harmonic scalpel technique (HST) had least operative time, least intra-operative blood loss, took minimum time for resumption of normal diet and normal activity and also had least pain score on post-operative day 1st, 5th, 10th and 15th. STATISTICS: Kruskall-Wallis and the non-parametric Analysis of variance (ANOVA) tests were applied to determine statistically significant variances. All the differences are found to be significant P < 0.05. Harmonic Scalpel Technique (HST) is the latest technique as it is associated with quicker procedure, less intraoperative blood loss and less post-operative pain. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Endoscopic Adenoidectomy Replacing the Outdated Curette Adenoidectomy: Comparison of the Two Methods at a Tertiary Care Centre

paythelady.61 shared this article with you from Inoreader Endoscopic Adenoidectomy Replacing the Outdated Curette Adenoidectomy: Comparison of the Two Methods at a Tertiary Care Centre Via Latest Results for Indian Journal of Otolaryngology and Head Abstract To compare intraoperative and postoperative parameters of the two techniques of adenoidectomy, endoscope and microdebrider powered adenoidectomy and conventional adenoidectomy. Study Design Prospective study. Setting: Academic tertiary referral centre. In our study, cases of adenoid hypertrophy were randomly selected from the outpatient department of department of ORL & HNS. Out of these patients, 30 underwent Endoscopic adenoidectomy (EA) (Group A) and 30 underwent Conventional adenoidectomy (CA) (Group B). All of the patients were assessed pre-operatively, intra-operatively and post-operatively to compare the various parameters. The most common complaint in both the groups was mouth breathing with snoring. Intra-operative bleeding was 29.15 ml in group EA and 15.2 ml in group CA. Operative time for CA was shorter at 21.8 min as compared to 32.1 min for group EA. Residual adenoids and injury to adjacent structures were more common in group CA. Hospital stay was 3.2 days for EA patients and 3.43 days for CA patients. Resolution of symptoms was near comparable in both groups. Operative time and intra-operative bleeding are both significantly reduced with the CA as opposed to EA. However, injury to adjacent structures and residual adenoids occur significantly less in group EA. After weighing the risks and benefits, we can conclude that EA is comparatively better than CA. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Development and Validation of Instrument for Operative Competency Assessment in Selective Neck Dissection

paythelady.61 shared this article with you from Inoreader Development and Validation of Instrument for Operative Competency Assessment in Selective Neck Dissection Via SAGE-Journals: Annals of Otology, Rhinology & Laryngology: Table of Contents Annals of Otology, Rhinology &Laryngology, Ahead of Print. Background:Instruments to assess surgical skills have been validated for several key indicator procedures in otolaryngology. Selective neck dissection is a core procedure for which trainees must integrate knowledge of complex head and neck anatomy with technical surgical skills. An instrument for assessment of surgical performance in selective neck dissection has not been previously developed. The objective of the current study is to develop and validate an instrument for assessing surgical competency for level II-IV selective neck dissection.Design:A Delphi working group comprised of 23 fellowship trained head and neck surgeons from 17 institutions was assembled. The modified Delphi method encompassed a 3-step process, including 2 anonymous voting rounds to successively refine individual items and establish levels of consensus. Thresholds for achieving strong consensus, at >80% agreement, were determined a p riori. The resulting instrument was subsequently validated in a prospective cohort of 17 resident surgeons, spanning postgraduate year 1 to 5 training experience. Participants were asked to perform a level II-IV selective neck dissection on fresh-frozen cadaveric specimens. Performance was scored by 2 independent, blinded observers using the devised instrument and construct validity was assessed.Results:Through the modified Delphi process a final list of 30 items, considered to be the most essential items for achieving the goals of a level II-IV selective neck dissection, was developed. Construct validity was supported by a positive association between instrument scores compared to both resident postgraduate year level and number of head and neck rotations completed.Conclusion:The development and validation of a novel instrument for assessment of surgical competency in level II-IV selective neck dissection, a key indicator case in otolaryngology, is described. This new instrument ma y be used to provide objective feedback on overall and task-specific competency to identify surgical deficiencies and offer granular feedback to enhance surgical training. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Readmission Rates Following Major Head and Neck Surgery With Concurrent Tracheostomy

paythelady.61 shared this article with you from Inoreader Readmission Rates Following Major Head and Neck Surgery With Concurrent Tracheostomy Via SAGE-Journals: Annals of Otology, Rhinology & Laryngology: Table of Contents Annals of Otology, Rhinology &Laryngology, Ahead of Print. Objectives:To determine the influence of major head and neck procedures on readmission and complication rates following tracheostomy.Methods:A retrospective cohort study using the 2005 to 2017 National Surgical Quality Improvement Program (NSQIP) database. Current Procedural Terminology codes were used to identify tracheostomy patients and to define the underlying head and neck procedure. Patients under the age of 18 and with unknown pre-operative variables were excluded. Univariate and multivariable analyses were performed.Results:A total of 3240 tracheostomy patients undergoing major head and neck surgery were identified in NSQIP. The 30-day mortality rate was 104 (3.2%) and 258 (9.0%) patients were readmitted. 637 (19.7%) patients had an unplanned return to the operating room. There were 1606 (49.6%) non-tracheostomy specific complications, which included 850 (26.2%) medical and 1142 (35.2%) surgical complica tions. On multivariable analysis, we found that the underlying procedures did not impact the risk of readmission (P > .05 for all). The underlying procedure was also not associated with unplanned return to the operating room except for thyroidectomies, which had a lower risk than free tissue graft reconstruction (OR = 0.53 (95%CI 0.31, 0.88), P = .018).Conclusion:While almost 1 in every 2 patients had a complication following major head and neck surgery that included creation of a tracheostomy, the rate of readmission is comparatively low and is not associated with the underlying procedure. These findings should reassure head and neck surgeons that properly managed tracheostomies do not constitute a disproportionate risk of readmission. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

The Effect of Topical Tranexamic Acid in Endoscopic Sinus Surgery: A Triple Blind Randomized Clinical Trial

paythelady.61 shared this article with you from Inoreader The Effect of Topical Tranexamic Acid in Endoscopic Sinus Surgery: A Triple Blind Randomized Clinical Trial Via SAGE-Journals: Annals of Otology, Rhinology & Laryngology: Table of Contents Annals of Otology, Rhinology &Laryngology, Ahead of Print. Objective:Our aim is to evaluate the effect of topical tranexamic acid (TA) on bleeding and surgical quality field in the functional endoscopic sinus surgery (FESS).Methods:A total of 74 patients who underwent FESS due to chronic rhinosinusitis were included. The patients were randomized into 2 groups. TA group (n = 37) received a topical cotton pledget soaked with TA and placebo (PL) group (n = 37) received a pledget soaked with saline solution.Results:A significant effect was noted for the TA group versus the PL group in the grade 1 of the Boezaart scale at 35 minutes (4 for TA group and no case for PL group). This effect was absent for higher grades. We did not notice a significant effect between the 2 groups at 5 minutes. Blood loss was 359 ml in the TA group versus 441 ml in the PL group. No significant change was observed between the 2 groups concerning the blood parameters. No side effects were reported.Conclusion:Despite its safety when administrated locally and its low cost, TA provides limited effect on quality of surgical field after 35 minutes of the start of FESS in the patients with chronic rhinosinusitis. This effect was absent at the start of the intervention and when analyzing the blood loss and hematologic parameters. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Cervical Necrotizing Fasciitis and Free Tissue Transfer

paythelady.61 shared this article with you from Inoreader Eight Tales of Cervical Necrotizing Fasciitis and Free Tissue Transfer Via SAGE-Journals: Annals of Otology, Rhinology & Laryngology: Table of Contents Annals of Otology, Rhinology &Laryngology, Ahead of Print. Objectives:Aggressive surgical debridement is required in cervical necrotizing fasciitis, and in severe defects, subsequent free tissue transfer might be necessary. However, there is concern that the inflammatory environment of the infection site may threaten free flap viability, particularly with concerns for thrombosis of feeding vessels and compromised tissue integration. Cases in the head and neck area are rare, so there are limited data regarding outcomes of free tissue transfer in these patients.Methods:A retrospective chart review assessed patients with cervical necrotizing fasciitis treated at an academic tertiary hospital between 2015 and 2021. Twenty-five patients were identified, and eight required free tissue transfer after adequate surgical debridement. Treatment, hospital course, and demographic data were collected on these eight patients.Results:All flaps had full survival at follow up (median fol low up 3 months, range 1-39 months) without concerns for vascular compromise.Conclusion:These data suggest that in patients with large soft tissue defects due to cervical necrotizing fasciitis, free tissue transfer may be a safe treatment modality. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Benign paroxysmal positional vertigo

paythelady.61 shared this article with you from Inoreader Benign paroxysmal positional vertigo Via Auris Nasus Larynx Benign paroxysmal positional vertigo (BPPV) is characterized by positional vertigo (brief attacks of rotatory vertigo triggered by head position changes in the direction of gravity) and is the most common peripheral cause of vertigo. There are two types of BPPV pathophysiology: canalolithiasis and cupulolithiasis. In canalolithiasis, otoconial debris is detached from the otolithic membrane and floats freely within the endolymph of the canal. In cupulolithiasis, the otoconial debris released from the otolithic membrane settles on the cupula of the semicircular canal and the specific gravity of the cupula is increased. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.