This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

开始日期2024-02-01

申办/合作机构

Boston Biomedical Associates LLC

[+2]

NCT04409561 / CompletedN/A

A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.

开始日期2021-11-15

申办/合作机构

Abionic SA

[+1]

NCT04312763 / SuspendedN/A

A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals

This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.

开始日期2020-03-06

申办/合作机构

Second Sight Medical Products, Inc.

[+1]

100 项与 Boston Biomedical Associates LLC 相关的临床结果

登录后查看更多信息

0 项与 Boston Biomedical Associates LLC 相关的专利（医药）

登录后查看更多信息

项与 Boston Biomedical Associates LLC 相关的文献（医药）

2020-03-01·Molecular Genetics and Metabolism2区 · 生物学

5-year retrospective analysis of patients with phenylketonuria (PKU) and hyperphenylalaninemia treated at two specialized clinics

2区 · 生物学

Article

作者: Lindenberger, Jessica ; DiBona, Kevin ; Hawthorne, Sarah ; Vockley, Jerry ; Lamppu, Diana ; Baker, Jennifer L ; Anastosoaie, Vera ; Seymour, Albert ; Kinch, Deborah ; Levy, Harvey ; Watling, Sharon ; McIlduff, Mark

BACKGROUNDPhenylketonuria (PKU) is an autosomal recessive disease caused by mutations in the PAH gene, resulting in deficiency of phenylalanine hydroxylase (PAH), an enzyme that converts phenylalanine (Phe) to tyrosine (Tyr). The purpose of this study was to capture real-world data associated with managing PKU under current standard of care and to characterize a representative population for a planned gene therapy trial.METHODSA retrospective chart review was conducted at two U.S. clinics for individuals 10-40 years old diagnosed with PKU-related hyperphenylalaninemia (HPA). Demographics, medical history, treatments and blood Phe data were collected from electronic medical records spanning a five-year period ending in November 2017.RESULTS152 patients were enrolled (65.8% had classical PKU). Although >95% of patients were prescribed a Phe-restricted diet, blood Phe concentrations remained substantially elevated, particularly in patients diagnosed with classical PKU. As the Phe threshold was lowered (Phe < 600, 360, 120 or 30 μmol/L), the number of patients with consecutive lab values below the threshold decreased, suggesting that many patients' Phe levels are inadequately controlled. 62.5% of patients were reported as having a history of at least one neuropsychiatric comorbidity, and adults were more likely than adolescents (69.5% vs. 54.3%). 92 of 98 PAH genotypes collected were distinct mutations; the 6 null-null genotypes were associated with classical PKU. Overall the demographics and clinical data were consistent across both sites.CONCLUSIONDespite dietary restrictions, mean Phe concentrations were > 360 μmol/L (a level considered well-controlled based on current U.S. treatment guidelines) for mild, moderate, and classical PKU patients. There remains an unmet need for therapies to control Phe concentrations.

2017-09-01·Pain physician3区 · 医学

Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty.

3区 · 医学

Article

作者: McIlduff, Mark ; Tutton, Sean ; Warner, Christopher ; Beall, Douglas P ; Coe, Jeffrey D ; Hornberger, John ; Bloch, Daniel

BACKGROUNDThe KAST (Kiva Safety and Efficacy) investigation device exempt (IDE) study indicated that the majority of patients responded equally well to vertebral augmentation using either an implant-based approach or balloon kyphoplasty (BK). Additional investigation has suggested that a subset of patients may benefit further by avoiding repeated readmissions due to serious adverse events (SAEs) if they receive one vertebral augmentation approach over another.OBJECTIVESThe primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs.STUDY DESIGNThe KAST trial is a pivotal, multicenter, randomized, controlled trial conducted to evaluate an implant-based vertebral augmentation approach (implant) against BK. Post-hoc analysis was performed to evaluate SAEs and readmission rates.SETTINGTwenty-one sites in North America and Europe.METHODSThe treatment effect of vertebral implant versus BK on SAEs requiring unplanned readmission was evaluated by estimating the risk of SAEs associated with readmissions in KAST while controlling for key baseline covariates using multivariate Poisson regression modeling.RESULTSForty (27.8%) patients with implants had 69 SAEs associated with readmission compared to 44 (31.2%) patients with BK having 103 events. The risk for all SAEs leading to readmission was 34.4% lower with the implant than for BK (95% confidence interval = 11.1%, 51.7%; P < 0.01). Multivariate analysis showed that the risk of SAEs associated with readmission was decreased in subjects treated with the implant compared to BK, and increased in patients with prior histories of vertebral compression fractures (VCFs) or significant osteoporosis.LIMITATIONSThe power of the KIVA study was based on clinical efficacy criteria to meet FDA requirements and recommendations for equivalency or noninferiority. The primary endpoint in this post-hoc analysis is SAEs associated with readmissions; as a result, the sample size is underpowered, although the results remain significant.CONCLUSIONThe augmentation approaches compared here have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT01123512. Key words: Vertebral compression fracture, kiva implant, balloon kyphoplasty, vertebroplasty, health economics, osteoporosis.

2014-08-01·The Journal of Thoracic and Cardiovascular Surgery1区 · 医学

SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement. Part II. Mitral valve

1区 · 医学

Review

作者: Mack, Michael J ; Hijazi, Ziyad M ; Trento, Alfredo ; Horlick, Eric ; Feldman, Ted ; Ruiz, Carlos E ; Bavaria, Joseph ; Miller, D Craig ; Cameron, Duke E ; Mukherjee, Debabrata ; Moon, Marc R ; Dean, Larry S ; Cigarroa, Joaquin E ; Weiner, Bonnie H ; Bacha, Emile A ; Zahn, Evan ; Tommaso, Carl L ; Aldea, Gabriel S ; Bolman, R Morton ; Fullerton, David A

Cardiac Catheterization Laboratory, North Shore Shore University Health System, 9669 North Ke 60076; Cardiothoracic Surgery, University of Colo Colorado 88045-2527; Cardiac Catheterization Hospital, Evanston, Illinois 60201; Cardiology Di pital, Walgreen Building 3rd Floor, Evanston, Illinoi Washington School of Medicine, Seattle, Washin Regional Heart Center, 1959 NE Pacific, Box 356171 98195; Rush Center for Congenital & Structural H Illinois 60612; Pediatric Cardiology, Rush Unive Chicago, Illinois 60612; Peter Munk Cardiac Cen Hospital, Toronto, Ontario M5G2C4; Saint Vincent Medical Center/Fallon Clinic, Worcester, Massach medical Associates, Northborough, Massachusetts; Center, Los Angeles, California 90048; Departmen Health & Science University, 2761 SW Patton Ct., Po Lenox Hill Heart and Vascular Institute of New York 10021; Division of Cardiothoracic Surgery, delphia, Pennsylvania 19104; Cardiovascular C Hospital Baylor Plano, Plano, Texas 75093; The Da Broccoli Center for Aortic Diseases, The John

100 项与 Boston Biomedical Associates LLC 相关的药物交易

登录后查看更多信息

100 项与 Boston Biomedical Associates LLC 相关的转化医学

登录后查看更多信息