Channel Medsystems wins CE Mark for Cerene cryotherapy device

Channel Medsystems said today it won CE Mark approval in the European Union for its Cerene cryotherapy endometrial ablation device designed for treating women with heavy menstrual bleeding due to benign causes. The Emeryville, Calif.-based company said that current endometrial ablation procedures can be painful and require general anesthesia, but its Cerene device and associated procedure are comfortable and usable in an office setting with no post-procedure downtime. “Finding the right treatment can be a challenge for women. The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia,” Dr. Mark Emanuel of Utrecth, Netherland’s University Medical Center said in a prepared statement. “From inception, our team has worked to understand what women and gynecologists are seeking in a new treatment for heavy menstrual bleeding. We’ve integrated that feedback into our development process and are excited that women in Europe will now have access to a treatment that is intended to meet their unique needs,” CEO &prez Ric Cote said in a press release. Channel Medsystems said it has completed the treatment phase of a 242-woman pivotal study in the US as it collects data necessary for ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Women's Health Channel Medsystems Source Type: news

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CONCLUSIONS: Reconstruction with a small artery-only free medial flap transfer of the second toe led to satisfactory sensory and motor function in the selected patients with fingertip injuries.
Source: Clinics - Category: General Medicine Source Type: research
DiscussionOur case series illustrates the difficulty in managing patients with anaphylaxis to replacement therapy. In the era of novel therapies, such as emicizumab, the management of HA patients who experience anaphylaxis to replacement therapy is becoming easier and may obviate the need for ITI. Current treatment strategies for HB patients with such anaphylaxis, however, are limited to rFVIIa, and it continues to pose a challenge.
Source: Blood Cells, Molecules, and Diseases - Category: Hematology Source Type: research
The objective of this article is to detail our surgical approach to the anatomic GreenLight laser vaporization-incision technique using the XPS LBO-180W system, based on extensive personal experience with both enucleation and vaporization techniques using various laser technologies. Standardization of the VIT based on proper cystoscopy, knowledge of prostate anatomy with preoperative ultrasound, and routine technique is essential to developing consistent, reproducible and optimal surgical outcomes. PMID: 31629449 [PubMed - in process]
Source: Canadian Journal of Urology - Category: Urology & Nephrology Tags: Can J Urol Source Type: research
Condition:   Leukemia, Myeloid, Acute Intervention:   Sponsor:   Assistance Publique - Hôpitaux de Paris Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
We report a case in which 12  years after a successful left carotid endarterectomy, a carotid-cutaneous fistula resulted in pulsatile bleeding from the neck that necessitated urgent intervention and surgical reconstruction.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
This study reviewed the outcome of patients subjected to thoracic endovascular aortic repair (TEVAR) under full, low-dose, and no intraoperative systemic heparinization.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
Synthetic marijuana use has been reported in the last years as a possible causative factor of different cardiovascular events, including myocardial infarction, ischemic stroke, intracranial bleeding, and cerebral vasospasm. One case of aortic thrombosis was also reported, but that was in a patient using cocaine and synthetic marijuana together. A case of lower limb thromboembolism and synthetic marijuana use has not been reported to date. Intoxication, material impurity, blood vessel reactivity, and chemical interaction with other drugs have been proposed as possible mechanisms of these events.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
Catheter-directed thrombolysis (CDT) is a recommended method for acute deep venous thrombosis with the advantage on enhancing thrombus removal of lower extremities, reducing the post-thrombotic syndrome and the risk of threatened limb loss. Recently, the mechanical devices combined with CDT treatment have shown its advantage over CDT alone in some reports. Fibrinogen levels are typically serially monitored during the infusion period and used as a surrogate marker for impending bleeding. We aimed to demonstrate the advantage of catheter and aspiration thrombectomy (CAT) over CDT on the changes of fibrinogen level.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
Publication date: Available online 20 October 2019Source: Journal of Cardiology CasesAuthor(s): Ryo Eto, Hiroaki Kawano, Ichiro Horie, Kenichi Kaneko, Takuya Honda, Kuniko Abe, Seiji Koga, Satoshi Ikeda, Koji MaemuraAbstractA 65-year-old Japanese woman with an intrapericardial tumor and neck tumor was admitted to our hospital. Intrapericardial tumor had not been resected because of massive bleeding from the hypervascular tumor and its invasion into the pericardium, ascending aorta, and pulmonary artery. The neck tumor had been successfully resected, and paraganglioma was pathologically diagnosed. Abnormal accumulation in t...
Source: Journal of Cardiology Cases - Category: Cardiology Source Type: research
AbstractPurpose of ReviewThe purpose of this review is to synthesize and summarize recent developments in the care of patients with end-stage heart failure being managed with a left ventricular assist device (LVAD) as destination therapy.Recent FindingsAlthough the survival of patients treated with LVAD continues to improve, the rates of LVAD-associated complication, such as right ventricular failure, bleeding complications, and major infection, remain high, and management of these patients remains challenging.SummaryThe durability and hemocompatibility of LVAD support have greatly increased in recent years as a result of ...
Source: Current Heart Failure Reports - Category: Cardiology Source Type: research
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