patient id News
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Endospan Enrolls First Patient in the TRIOMPHE IDE Study
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, announces the first implant of the NEXUS™ Aortic Arch Stent Graft System on a patient with a thoracic aortic aneurysm as part of the TRIOMPHE Study in Norfolk, Virginia, January 11, 2021. The TRIOMPHE Study is a multi-arm, multi-center, non-randomized, prospective, clinical study to evaluate the safety and ...
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Cerapedics Announces Canadian Approval of its next-generation bone graft
Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ ...
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V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure
V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF). V-Wave’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, ...
By V-Wave Ltd.
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Cerapedics Announces Publication of Results of Study Evaluating the Cost-Effectiveness of i-FACTOR vs. Local Autologous Bone in ACDF Surgery
Cerapedics Inc., a private ortho-biologics company dedicated to enhancing the science of bone repair, announced today that results of a study to evaluate the cost-effectiveness of i-FACTOR Peptide Enhanced Bone Graft compared to autograft for patients undergoing ACDF surgery were recently published in ClinicoEconomics and Outcomes Research (July 2021, Volume 2021, Issue 13). In this landmark ...
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Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a ...
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Nyxoah Provides General Corporate Update
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today provided a general corporate update. 2021 Highlights Implanted first U.S. patient in the DREAM IDE pivotal study in December 2020; there are currently ...
By Nyxoah SA
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Halo Labs Launches The Aura Cl™ For Cell Therapy Product Quality – PR Newswire
Halo Labs, a life science instrumentation company developing tools for biologics researchers, today announced it has launched its latest product, called the Aura CL. The Aura CL is the next generation in Halo Labs’ popular family of instruments. Using Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy the Aura CL can distinguish therapeutic cells from contaminants and ...
By Halo Labs
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Synchron Announces Enrollment of First Patient in U.S. Endovascular Brain Computer Interface Study COMMAND in Patients With Severe Paralysis
Synchron and Mount Sinai Hospital in New York Advance Industry-First FDA-Approved Clinical Trial for Brain-Computer Interface in U.S. Paralysis is a devastating condition for more than 5 million patients in the United States Synchron, an endovascular brain-computer (BCI) interface company, today announced the enrollment of the first patient in the US clinical trial, COMMAND, for patients ...
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BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announces the designation of a new reimbursement code for the CardiAMP® Cell Therapy procedure to transplant autologous bone marrow cells to treat heart failure from the U.S. Center for Medicare and Medicaid Services (CMS). This new CMS code to ...
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FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval
FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial ...
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Adagio Medical Announces First Patient Enrollment in its iCLAS U.S. IDE Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Persistent Atrial Fibrillation
Adagio Medical, Inc. (Adagio) today announced it has enrolled the first patient in its iCLAS™ Investigational Device Exemption (IDE) trial. The FDA approved study aims to evaluate the safety and efficacy of Adagio’s ultra-low temperature intelligent Continuous Lesion Ablation System (iCLAS) in the treatment of persistent atrial fibrillation (PsAF). Data will be used to support a ...
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Cerapedics Announces FDA approval of an IDE supplement
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...
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Anteris reports successful interim results for the first-in-human trial for DurAVR
Anteris Technologies Ltd (ASX: AVR) reports the first-in-human DurAVR™ THV study met or exceeded its interim study objectives. At the 30-day follow up point, the first five patients of the planned 10-patient study showed: All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention). An average 86% improvement in mean ...
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iSTAR Medical shows initial positive progress of US STAR-V trial for MINIject
Pivotal trial of MINIject, STAR-V, now initiated in 13 sites across the US Positive feedback from world-leading glaucoma surgeons involved in the trial MINIject is the only commercially available MIGS device targeting the supraciliary space. Commercial rollout continues following European approval in 2021 WAVRE, Belgium — 12 January 2022: iSTAR Medical, a medtech company delivering ...
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