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Merit Medical backs Bluegrass Vascular ’ s Surfacer ‘ inside-out ’ catheter
Bluegrass Vascular Technologies said today that it entered a “strategic relationship” with Merit Medical (NSDQ:MMSI) for its Surfacer “inside-out” catheter that includes an equity stake and a distribution agreement.
The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union last August. The catheter is threaded through the femoral vein up to and into blockage in the jugular, which acts as a stabilizer. The head of the catheter is then aligned via fluoroscop...
Source: Mass Device - March 6, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Distribution Funding Roundup Vascular Wall Street Beat Bluegrass Vascular Technologies Merit Medical Systems Inc. Source Type: news
Outset Medical raises $76.5m Series C to support Tablo all-in-1 hemodialysis system
Outset Medical said today it raised $76.5 million in a Series C equity funding round to support its Tablo hemodialysis system.
The Tablo system is an all-in-one dialysis machine which handles both water purification and dialysate production and is designed to be used in a variety of settings, CEO Leslie Trigg told MassDevice.com.
The system is equipped with a touch screen interface and designed to be used by even the most basic user, Trigg said, something that sets it apart from other hemodialysis systems on the market.
“We designed it so that it’s acceptable for the average patient user to set up and manage their...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Outset Medical Source Type: news
Outset Medical raises $4m
Outset Medical has raised $4.3 million in a new round of mixed financing, according to an SEC filing posted this week.
The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be used in a variety of different settings.
Money in the round came from a single investor, with the 1st sale recorded on June 30, according to the filing. Sales in the round included debt, options and securities from exercisable options.
Outset Medical has not yet stated how it plans to use funds raised in the round.
The fun...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Outset Medical Source Type: news
Exthera Medical wins FDA EAP designation for Seraph 100 blood filter
Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation.
The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE and MRSE,” the company said.
“We submitted our EAP application in early June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation with...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance ExThera Medical Source Type: news
TVA Medical touts meta-analysis of everlinQ endoAVF treatments
TVA Medical today released data from a meta-analysis study of its everlinQ endovascular arteriovenous fistula system designed for hemodialysis access, touting a high procedure success rate and a high rate of fistula maturation.
Results from the 236-patient trial were presented at the Leipzig Interventional Course 2018, the Austin, Texas-based company said.
Data in the meta-analysis came from four clinical studies and 79 commercial cases, and indicated a 96.8% and 97.8% procedure success rate in clinical studies and real-world cases, respectively, as well as an acceptable safety profile.
The results also indicated 88% fistu...
Source: Mass Device - February 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular TVA Medical Source Type: news
FDA grants de novo clearance to Avenu Medical for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won FDA de novo clearance for its Ellipsys vascular access system designed for use with end-stage renal disease patients who require hemodialysis.
The San Juan Capistrano, Calif.-based company touted that its Ellipsys EndoAVF technology acts as an alternative to traditional AV fistula creation. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF.
“Using the Ellipsys vascular access system ...
Source: Mass Device - June 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Avenu Medical Source Type: news
BD closes TVA Medical buy
Becton Dickinson (NYSE:BDX) wasted no time in closing the cash buyout of TVA Medical, which just a few weeks ago landed FDA clearance for its EverlinQ EndoAVF hemodialysis device, for an undisclosed amount.
Austin, Texas-based TVA won de novo clearance June 22 for the EverlinQ EndoAVF device, which uses a pair of magnetic catheters and radiofrequency energy to create an arteriovenous fistula for hemodialysis access without open surgery. BD said today that it plans to change the system’s name to WavelinQ EndoAVF as it integrates TVA into its peripheral intervention business.
“The FDA’s authorization a...
Source: Mass Device - July 9, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Mergers & Acquisitions bectondickinson TVA Medical Source Type: news
Avenu Medical wins CMS reimbursement for Ellipsys dialysis device
Vascular access system maker Avenu Medical said last Friday it won a HCPCS C-Code from the Centers for Medicare and Medicaid Services for its Ellipsys dialysis device and the endoAVF procedure.
The San Juan Capistrano, Calif.-based company’s Ellipsys vascular access system device is designed for use with end-stage renal disease patients who require hemodialysis. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF.
The newly granted HCPCS reimbur...
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Vascular Avenu Medical Source Type: news
Age is not a risk factor in survival of severely ill patients with co-morbidities in a medical intensive care unit
ConclusionAge and gender were not found to be predictors of mortality. There was no survival advantage between young and elderly patients. Co-morbid diseases, apart from malignancy, had no effect on mortality. In developing countries, where patients with terminal illness and multiple co-morbid diseases are treated in the ICU, age should not be a determining factor in patient selection for ICU or in the treatment decisions to be applied to patients.
Source: Irish Journal of Medical Science - July 3, 2020 Category: General Medicine Source Type: research
Fine-tuned continuous renal replacement therapy with calcium-free dialysate to manage severe hypercalcemia refractory to medical and intermittent hemodialysis
AbstractMalignancy-related hypercalcemia is a leading cause of hypercalcemia among hospitalized patients that carries poor prognosis. Parathyroid carcinoma is a rare form of primary hyperparathyroidism that may be associated with PTH dependent hypercalcemia. Severe hypercalcemia is life-threatening and may require management in an intensive care unit by means of medical therapy consisting of volume expansion, loop diuretics, cinacalcet, calcitonin and bisphosphonates. Renal replacement therapy such as intermittent hemodialysis has been successfully used among patients with severe hypercalcemia who become refractory to medi...
Source: European Journal of Medical Research - June 8, 2022 Category: Research Source Type: research
CryoLife deals Hero graft to Merit Medical for $19m
CryoLife Inc. (NYSE:CRY) said today that it dealt its Hero hemodialysis access graft to Merit Medical (NSDQ:MMSI) for $18.5 million in cash.
The Hero graft put up $7.5 million in sales for CryoLife last year, the Atlanta-based company said. The deal calls for CryoLife to continue manufacturing the device for up to 6 months, when Salt Lake City-based Merit will take over production.
“The recent acquisition of On-X Life Technologies strengthened our strategic focus on aortic and mitral valve repair and replacement surgery. The transaction more than doubled our U.S. cardiac surgery sales force. The sale of the Hero gr...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Dialysis Mergers & Acquisitions Wall Street Beat CryoLife Merit Medical Systems Inc. Source Type: news
Intra‐dialytic exercise training: a pragmatic approach
SUMMARY
This continuing education paper outlines the skills and knowledge required to plan, implement and evaluate a pragmatic approach to intra‐dialytic exercise training.Aim: The aim of this continuing education article is to enable the nephrology multi‐disciplinary team (MDT) to plan, implement and evaluate the provision of intra‐dialytic exercise training for patients receiving haemodialysis therapy.LEARNING OUTCOMES: After reading this article the reader should be able to:
Appreciate the level of evidence base for the clinical effectiveness of renal exercise rehabilitation and locate credible sources of researc...
Source: Journal of Renal Care - June 1, 2014 Category: Urology & Nephrology Authors: Sharlene A. Greenwood, Patrick Naish, Rachel Clark, Ellen O'Connor, Victoria A. Pursey, Iain C. Macdougall, Thomas H. Mercer, Pelagia Koufaki Tags: CONTINUING EDUCATION Source Type: research
Knowledge of and adherence to standard precautions in a hemodialysis unit: a cross-sectional study
CONCLUSION: Knowledge of the SPs that had been established did not mean mastery of the subject. Despite positive results regarding adherence, factors requiring improvement were observed. It was possible to infer the characteristics that gave rise to greater risk of occurrences of accidents at work. Thus, this study showed the importance of assessing knowledge of and adherence to SP, in order to optimize and direct continuing education towards resolving occupational exposure.PMID:35239834 | DOI:10.1590/1516-3180.2021.0288.23072021
Source: Sao Paulo Medical Journal - March 3, 2022 Category: General Medicine Authors: Laura Prado Medeiros Kamila Silva de Miranda Thayna Martins Gon çalves Deusd élia Dias Magalhães Rodrigues Karen Renata Nakamura Hiraki Marilia Duarte Valim Monica Taminato Richarlisson Borges de Morais Source Type: research
