CSA Medical wins another FDA expansion for TruFreeze cryotherapy

Endoscopic cryo-ablation company CSA Medical said today it won expanded FDA 510(k) clearance for its TruFreeze spray cryotherapy system, now cleared for use on patients with Barrett’s esophagus with low grade dysplasia. With the clearance, the device is now approved for both low and high grade dysplasia as well as malignancies, the Boston-based company said. “Over the past few years, studies have underscored the potential risk for Barrett’s esophagus with low grade dysplasia to progress to esophageal adenocarcinoma. Intervening at this level of dysplasia has become common practice and is recognized in our society guidelines.  My colleagues and I have used liquid nitrogen spray cryotherapy for over a decade to treat Barrett’s esophagus with high levels of efficacy and patient tolerability.  With approval of this expanded label, the FDA has recognized spray cryotherapy’s ability to positively impact the lives of our Barrett’s patients,” Dr. Michael Smith of New York’s Mount Sinai hospitals said in a press release. The TruFreeze system is designed as a cryosurgical tool designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions. The company touts the TruFreeze device as the only ablation technology designed to ablate Barrett’s Esophagus with a high grade dysplasia or cancers as such as in the esophagus with a non-contact liquid nitrogen spray cryotherapy sy...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance CSA Medical Inc. Source Type: news

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Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news
Conditions:   Esophagus Cancer, Adenocarcinoma;   Stomach Cancer, Adenocarcinoma Interventions:   Drug: Rucaparib;   Drug: Ramucirumab;   Drug: Nivolumab Sponsors:   Anwaar Saeed;   Bristol-Myers Squibb;   Clovis Oncology, Inc. Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
CONCLUSION: This regimen demonstrated promising activity. Toxicity was significant, with seven study-related deaths leading to closure after stage 1. All postoperative deaths were due to ARDS. This regimen is not recommended. IMPLICATIONS FOR PRACTICE: Esophageal cancer is a disease with a high death rate. The current treatment involves giving chemotherapy plus radiation followed by surgery, but this cures only a quarter of patients. In order to improve survival, better treatments are needed. This trial evaluated the addition of a novel drug, cetuximab, to chemotherapy plus radiation. Unfortunately, the side effects w...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research
Background: Neoadjuvant chemoradiation (CRT) remains controversial in the treatment of the oesophagus or gastro-oesophageal junction (GOJ) carcinomas.Methods: We conducted a meta-analysis to assess the efficacy and safety of Neoadjuvant CRT plus surgery comparing with neoadjuvant CT plus surgery or surgery alone. Feasible studies were searched from electronic databases. The outcomes of survival, R0 resection rate and adverse effects were analyzed. The outcomes were measured with relative risk (RR) and odds ratio(OR).Results: Seventeen records including 4095 patients were included. Neoadjuvant CRT improved 1-,2-,3-and 5-yea...
Source: Journal of Cancer - Category: Cancer & Oncology Authors: Tags: Research Paper Source Type: research
Conclusion: HIV-infected individuals with low CD4 count are at highest risk for ESCC, but HIV infection was not independently associated with EAC or gastric cancer after adjusting for confounders.
Source: JAIDS Journal of Acquired Immune Deficiency Syndromes - Category: Infectious Diseases Tags: Epidemiology Source Type: research
ConclusionsThus, Sec61 α measurement has not an additional prognostic benefit for the patients.
Source: Journal of Cancer Research and Clinical Oncology - Category: Cancer & Oncology Source Type: research
Purpose of review The management of esophageal cancer has not changed significantly over the last decade. Survival rates remain poor in locally advanced and metastatic disease. Newer treatment modalities are desperately needed if we are to improve 5-year overall survival rates. Immunotherapeutic strategies hold great promise, but a much greater understanding of the immune microenvironment underlying squamous cell and esophageal adenocarcinoma is needed if we are to exploit the inherent cancer fighting capabilities of each patient's immune system. Recent findings Here we describe current and future predictive biomarker...
Source: Current Opinion in Gastroenterology - Category: Gastroenterology Tags: ESOPHAGUS: Edited by Stuart J. Spechler Source Type: research
Conclusions: IL-7 protein is overexpressed in EC, GC, and CRC, but concentrations differ both in tumor and tumor-adjacent tissue with respect to tumor location. More advanced cancers have lower IL-7 concentrations in the immediate environment of the tumor. At the systemic level, IL-7 is elevated in CRC and EC, but not CC or GC. IL-7 dependence on the location of the primary tumor should be taken into account in future IL-7-based immunotherapies. Functional studies explaining a role of IL-7 in gastrointestinal cancers are needed. PMID: 31185636 [PubMed - in process]
Source: Medicina (Kaunas) - Category: Universities & Medical Training Authors: Tags: Medicina (Kaunas) Source Type: research
This study demonstrates that visceral adipose tissue modulates the cellular response to radiation in OAC. PMID: 31171903 [PubMed - in process]
Source: International Journal of Medical Sciences - Category: Biomedical Science Tags: Int J Med Sci Source Type: research
AbstractIn the West, the incidence of esophageal adenocarcinoma, which is a long-term complication of damage by gastroesophageal reflux, has been rising over recent decades. Two main factors are likely to account for this increase. The first is the rising incidence of central obesity which promotes gastroesophageal reflux. The second is the falling incidence ofH. pylori infection and associated atrophic gastritis which reduces the acidity and peptic activity of gastric juice, the main factors damaging to the esophageal mucosa. The rise in esophageal adenocarcinoma has been mirrored by a fall in gastric cancer consistent wi...
Source: Journal of Gastroenterology - Category: Gastroenterology Source Type: research
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