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

Avania 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 Avania LLC 相关的临床结果

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0 项与 Avania LLC 相关的专利（医药）

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

BACKGROUND:

Phenylketonuria (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.

METHODS:

A 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.

RESULTS:

152 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.

CONCLUSION:

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

BACKGROUND:

The 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.

OBJECTIVES:

The primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs.

STUDY DESIGN:

The 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.

SETTING:

Twenty-one sites in North America and Europe.

METHODS:

The 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.

RESULTS:

Forty (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.

LIMITATIONS:

The 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.

CONCLUSION:

The augmentation approaches compared here have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT01123512. Key words: Vertebral compression fracture, kiva implant, balloon kyphoplasty, vertebroplasty, health economics, osteoporosis.

2014-08-01·The Annals of thoracic surgery2区 · 医学

SCAI/AATS/ACC/STS Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement: Part II. Mitral Valve

2区 · 医学

Review

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

项与 Avania LLC 相关的新闻（医药）

2019-01-06

·SYNAPSE

Factory CRO and Boston Biomedical Associates Announce Merger

BILTHOVEN, Netherlands & MARLBOROUGH, Mass.--([BUSINESS WIRE](https://www.businesswire.com/))--[Factory-CRO Group](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.factory-cro-group.com%2F&esheet=51921263&newsitemid=20190107005358&lan=en-US&anchor=Factory-CRO+Group&index=1&md5=a74d10620b79796a94b9fd7d7a6e7405), a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), and [Boston Biomedical Associates](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bbacro.com%2F&esheet=51921263&newsitemid=20190107005358&lan=en-US&anchor=Boston+Biomedical+Associates&index=2&md5=0b1c27ba2098662444307e83311632ce) (BBA) a premier full-service Medical Device/Biotechnology CRO and Consultancy based in the United States announce that they have merged the organizations. > This merger allows us to provide our specialized expertise and a continued commitment to the highest level of customized service to a larger audience. Now we are the only Medical Device and Medical Technology CRO that offers services in US, Eur, AU and NZ > > [Post this](https://www.businesswire.com/news/home/20190107005358/en/Factory-CRO-and-Boston-Biomedical-Associates-Announce-Merger#) The merger further advances the shared strategic vision to become the leading Global Medical Device and Medical Technology focused CRO. Following the recent acquisitions of MileStone Research Organization, Five Corners, and Clinical Device Group the Factory-CRO Group now has specialized operations and expertise in the United States, Australia/New Zealand, and Europe. This global expansion coupled with the diverse medical therapeutic expertise provides a means to efficiently service clients. “BBA is excited to join Factory-CRO’s worldwide group as it will allow us to expand our comprehensive service offering to our clients,” said Lauren Baker, PhD, President and CEO of BBA. “The alignment of Factory-CRO and BBA’s core values and approach to engagements combined with our collective therapeutic competencies ensures that our clients now have improved access to our global clinical trial execution resources, and our regulatory and medical expertise.” Dr. Baker then added, “We are able to fully support our clients as their needs evolve and they strive to help patients globally.” “We are honored to have the BBA team join the Factory-CRO Group,” said Dirk Meijer, MD, MSc,PhD, Factory-CRO CEO. “BBA’s ability to provide CRO/Consultative service in North America was a missing link in our global offerings.” Dr. Meijer then added, “Our clients have consistently asked us to expand our offerings in North America. This merger allows us to provide our specialized expertise and a continued commitment to the highest level of customized service to a larger audience. Now we are the only Medical Device and Medical Technology CRO that offers services in United States, Europe, Australia and New Zealand. We operate from our own offices located within each region housed with employees that have refined expertise to meet our unique client needs.” About Factory-CRO Group: Factory-CRO Group is a leading, full-service contract research organization focused on the management of clinical studies for medical devices, IVDs, biologics and device-drug combination products internationally. Founded in 1992, the business offers a full suite of trial management services to its global client base across a broad range of therapeutic areas, including orthopedic, cardiovascular, dermatology and aesthetics. Current members of Factory-CRO Group are: BBA, Five Corners CRO, Milestone Research group and Factory-CRO. For more information about Factory-CRO, visit their website, [www.factory-cro.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.factory-cro.com&esheet=51921263&newsitemid=20190107005358&lan=en-US&anchor=www.factory-cro.com&index=3&md5=a385daf580423d631e1ca6b4f827796c) or contact Joris Bannenberg, MD, PhD, Factory-CRO’s CMO: Joris Bannenberg, MD, PhD CMO [j.bannenberg@factory-cro.com](mailto:j.bannenberg@factory-cro.com) +31 30 229 2727 (x108) About Boston Biomedical Associates: Boston Biomedical Associates (BBA) is a premier full-service Medical Device/Biotechnology CRO and Consultancy firm. Founded in 2000, by Lauren Baker, Ph.D., this leading CRO has earned a reputation for its comprehensive approach to clinical trial execution services to its global client base across a broad range of therapeutic areas, including orthopedic, cardiovascular, endocrine and neurologic disorders. For more information about BBA, visit their website, [www.bbacro.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bbacro.com%2F&esheet=51921263&newsitemid=20190107005358&lan=en-US&anchor=www.bbacro.com&index=4&md5=ef4d7abacbf71afcadd4dd5ff825db47) or contact Mack Rubley, PhD, BBA’s Vice President of Business Development and Marketing: Mack D. Rubley, PhD VP, Business Development and Marketing 702-808-3494 [mrubley@bbacro.com](mailto:mrubley@bbacro.com)

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