hemodialysis News
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Xeltis opens new horizons in hemodialysis at VERVE
To learn how Xeltis’ restorative hemodialysis access graft, aXess, may be opening new horizons for patients with kidney failure, tune in the Visionary Endovascular and Vascular Education (VERVE) Symposium in Sidney, up to 4 December. In his talk on Saturday 4 December (10am AET), Professor Frans L. Moll, University Medical Center, Utrecht (NL) will explain how the Xeltis synthetic device ...
By XELTIS BV
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Cara Therapeutics Announces Biomarker Data from KALM-1 and KALM-2 Trials of KORSUVA (difelikefalin) Injection Selected for Presentation at National Kidney Foundation Spring Clinical Meetings 2022
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced biomarker data from the KALM-1 and KALM-2 clinical trials evaluating KORSUVA™ (difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing ...
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Potrero Medical Announces Appointment of New Chief Financial Officer
Potrero Medical announced today that Jeff Mack is joining its executive leadership team as its Chief Financial Officer (CFO) and will report to CEO Joe Urban. Jeff brings more than 30 years of finance and capital markets experience to Potrero Medical. He also has in-depth knowledge of scaling medical technology startups into significant success stories. “I couldn’t be more thrilled ...
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Alkahest Announces Initiation of Phase 2 Study AKST1210-201 Exploring Treatment of Cognitive Impairment in End Stage Renal Disease Patients
Alkahest Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, today announced the initiation of a clinical study to explore the use of an extracorporeal medical device to remove excess Beta-2 microglobulin (B2M) from circulation for the treatment of cognitive impairment in patients undergoing hemodialysis for ...
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Vascular experts discuss aXess in dialysis patients
Vascular surgeon and professor of vascular surgery at Università dell’Insubria in Italy, and Frans L. Moll, MD, PhD, professor emeritus of vascular surgery at the University Medical Center Utrecht in The Netherlands, provided insights on the progress of the aXess trial in an interview with Healio Nephrology. For more on Xeltis’ aXess, the first restorative synthetic ...
By XELTIS BV
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FDA grants new QIDP Designation Status for BTX 1801
Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801. This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central ...
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First restorative hemodialysis access graft implanted in patients
Xeltis has initiated the clinical trial for aXess, the first-ever restorative synthetic haemodialysis access graft. Several patients with kidney failure or advanced kidney disease requiring dialysis have already been successfully implanted as part of a European first-in-human trial to date. The aXess grafts enable early puncturing, or initiation of the dialysis, shortly after implanting. ...
By XELTIS BV
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Bluegrass Vascular Announces New Paper Reporting Ability to Eliminate Use of a Femoral Catheter with the Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a case report demonstrating the ability to utilize the Surfacer® System to perform the Inside-Out® procedure and obtain right-sided central venous access in a patient with central venous occlusion and ...
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Healionics Receives SBIR Grant from National Institutes of Health to Develop Needle Free Dialysis Access Devices
Healionics Corporation has received a $224,500 Small Business Innovation Research (SBIR) grant award from the National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health (NIH) for preclinical studies to develop a novel vascular graft for use with needle-free hemodialysis access ports. Andrew Marshall, PhD, Healionics’ Chief Technology ...
By Healionics
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Tablo Hemodialysis System Cartridge Receives FDA 510(k) Clearance Enabling Production in North America
Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company reducing the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a new sterilization method of the cartridge utilized in its Tablo® Hemodialysis System, enabling full production in North America. The Tablo cartridge is a ...
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Cara Therapeutics to Present at the 21st Annual Needham Virtual Healthcare Conference
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on Monday, April 11, 2022, at 1:30 p.m. ET. ...
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Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd., and its sublicensee Kissei Pharmaceutical Co., Ltd., confirmed the primary endpoint was achieved in a Japanese Phase 3 clinical study ...
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Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer System Procedure
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (APC) assignment ...
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Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients First launches in Europe expected in H2 2022 Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Commission has granted marketing authorization to Kapruvia® (difelikefalin) for the ...
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Cara Therapeutics to Present at May Investor Conferences
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the following investor conferences in May: BofA Securities 2022 Healthcare Conference Tuesday, May 10, 2022, at 2 p.m. ...
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Cara Therapeutics to Present at Upcoming Investor Conferences
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the following investor conferences: H.C. Wainwright Global Investment Conference Wednesday, May 25, 2022, at 10:30 a.m. ...
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Axio Biosolutions receives another FDA clearance for Axiostat Patch for Vascular Bleeding Control
Axio Biosolutions, an integrated wound care company has announced FDA 510(k) clearance of its hemostatic product, Axiostat Patch that helps control moderate to severe bleeding in vascular procedures, surgical debridement sites, puncture sites and more. Axiostat Hemostatic Patch is based on a protonated bioadhesive technology which works by providing a strong mechanical barrier to the injury ...
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Pollet Medical Group integrates Hemotech & Hema.T Medical
Pollet Medical Group, part of Pollet Group and mainly known for its water treatment activities under Pollet Water Group, integrates Hemotech & Hema.T Medical into their group. Both French companies are renomated experts in the market of hemodialysis and apheresis for dialysis centres and hospitals. Hemotech & Hema T. Medical deliver high quality medical devices intended to dialysis and ...
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Bluegrass Vascular Announces Publication Reporting Long-term data following facilitation of HeRO graft placement using the Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a report three cases where the Surfacer System was used to help facilitate the placement of the HeRO graft in patients with thoracic central venous obstruction (TCVO) where other methods for crossing the ...
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Kapruvia® receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients
Committee for Medicinal Products for Human Use (CHMP) recommends approval of Kapruvia® (difelikefalin) as first therapy in Europe for the treatment of chronic kidney disease associated-pruritus (CKD-aP) in hemodialysis patients European Commission decision for EU Marketing Authorization is expected in Q2 2022 Kapruvia® is approved in the U.S. under the trade name KORSUVA™ ...
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