A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement
用于经导管主动脉瓣置换的新型聚合物瓣膜
基本信息
- 批准号:10464978
- 负责人:
- 金额:$ 59.43万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-04-01 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAdverse eventAnimalsAortic Valve StenosisBenchmarkingBiological AssayBiological MarkersBioprosthesis deviceBlood PlateletsBlood VesselsBusinessesCardiacCardiovascular systemCathetersChronicClinicalClinical ResearchClinical TrialsCollaborationsComplicationCorrosionCoupledCyclic GMPDepositionDeteriorationDevelopmentDevicesDimensionsDistalEmbolismEuthanasiaEventExtravasationFailureFollow-Up StudiesFreezingFutureGenerationsGeometryGoalsGrantGuidelinesHeartHeart ValvesHemolysisHistologicImplantIn SituIn VitroInstitutionLeftLifeLife Cycle StagesLongterm Follow-upManufacturer NameMeasuresMedical DeviceMethodologyMicroscopicMoldsMolecular ConformationMonitorNational Institute of Biomedical Imaging and BioengineeringOperative Surgical ProceduresOrganOutcomePathologyPatientsPerformancePhasePlant RootsPolymersPopulationPrincipal InvestigatorProceduresProcessProsthesisRadialRegulationResistanceRiskRisk FactorsSafetySavingsSerious Adverse EventSheepSmall Business Technology Transfer ResearchStandardizationStentsStressStrokeSurfaceSurgical ValvesSystemTechnologyTestingTherapeutic EmbolizationThickThrombosisTissuesTranslatingUnited States National Institutes of HealthUniversitiesVentricularWorkX-Ray Computed Tomographyaortic valveaortic valve disorderaortic valve replacementbasebiomaterial compatibilitybonecalcificationcommercializationcrosslinkcytotoxicitydesigneffective therapyefficacy testingexperimental studyfirst-in-humangenotoxicityheart imaginghemocompatibilityhemodynamicshigh riskimprovedin vitro testingin vivoin vivo evaluationinnovationmanufacturing processmechanical propertiesmeetingsmigrationminimally invasivenew technologynovelolder patientoxidationpatient populationperformance testspre-clinicalpressureprogramsprototypequantumreplicatorresearch and developmentsheep modelsimulationsuccessthrombogenesisthromboticvalve replacementverification and validation
项目摘要
Project Summary: A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement
Minimally invasive transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for the unmet
clinical need of inoperable patients with severe aortic stenosis (AS). Recent longitudinal follow-up studies of TAVR
patients however indicate that this procedure and associated technology may result in serious adverse events. Current
technology is based on tissue valves adapted to, but not specifically designed for TAVR. Those may sustain damage
during crimping as well as deployment, are susceptible to ‘bone-like’ calcific deposition, and suffer from limited
durability. In a collaboration between Stony Brook University and PolyNova Cardiovascular, Inc., we have developed
a novel valve that is specifically designed to tackle the numerous challenges that a TAVR valve will meet during its
life cycle, from crimping to deployment and long term performance in situ. It incorporates (i) novel polymer technology,
xSIBS, which combines superior bio-stability together with excellent mechanical properties, and (ii) a novel design
optimization methodology of the leaflets profile for enhanced hemodynamics, durability, and thromboresistance
performance.
Our broad objective is to develop a viable and durable TAVR valve that will propose a real alternative to existing
bioprosthetic aortic valves, and allow a long-term solution adequate for broader segment of the population. Following
a successful Phase I STTR project, in this Phase II project we aim to expand the R&D activities of our polymeric valve
toward First-In-Man, and implement a robust regulatory and quality management system plans.
The proposed project includes 4 Aims: Aim 1 expand our set of advanced computational flow simulations,
development of a 2nd generation valve, development of a dedicated delivery catheter system, and expanding our valve
product to a complete set of valve sizes. Aim 2 tests the valve performance according to the ISO 5840-3 (transcatheter
heart valves), ISO 25539-1 (cardiovascular implants), and ISO10993-1 (biocompatibility). We will also modify our
valve manufacturing capabilities to be compliant with the FDA quality management system. Aim 3 tests the valves in
vivo in sheep model. The valves are tested for efficacy and safety in acute tests as well as chronic 10 and 20 wks.
Aim 4 is dedicated for integrating regulatory and business plans for PolyNova and for the valve technology.
Integral to this STTR Phase II project is a detailed commercialization and regulatory plan, based on which, and under
the support of this Phase II program, we will convert PolyNova from a pure R&D shop to firm establishment as a
qualified medical device manufacturer– i.e. institution of a fully cGMP, FDA compliant Quality Management System
including a robust Design Control process.
Successful accomplishment of the above aims will lead to a breakthrough in the treatment of aortic valve diseases,
providing an affordable, long-term, minimally invasive solution, enhancing the life of a much broader patient
population.
项目总结:一种用于经导管主动脉瓣置换术的新型聚合物瓣膜
微创经导管主动脉瓣置换术(TAVR)已成为未满足的有效治疗方法
严重主动脉瓣狭窄(AS)患者不能手术的临床需求。TAVR近期纵向随访研究
然而,患者指出,该手术和相关技术可能导致严重的不良事件。电流
该技术基于适用于TAVR的组织瓣膜,但不是专门为TAVR设计的。那些可能会受到伤害
在卷曲和展开过程中,易受“骨样”钙化沉积的影响,
耐久性在斯托尼布鲁克大学和波利诺瓦心血管公司的合作中,我们已经开发
一种新型瓣膜,专门设计用于解决TAVR瓣膜在其植入过程中遇到的众多挑战。
生命周期,从压接到部署和长期原位性能。它结合了(i)新颖的聚合物技术,
xSIBS,其结合了上级生物稳定性和优异的机械性能,和(ii)新颖的设计
优化瓣叶轮廓的方法,以增强血液动力学、耐久性和抗血栓性
性能
我们的广泛目标是开发一种可行且耐用的TAVR瓣膜,为现有的TAVR瓣膜提供真实的替代方案。
生物假体主动脉瓣,并允许长期解决方案适用于更广泛的人群。以下
作为一个成功的一期STTR项目,在二期项目中,我们的目标是扩大我们聚合物阀门的研发活动
迈向第一人,并实施一个强大的监管和质量管理体系计划。
拟议的项目包括4个目标:目标1扩展我们的先进计算流模拟集,
开发第二代瓣膜,开发专用输送导管系统,并扩展我们的瓣膜
我们的产品适用于一整套阀门通径。目标2根据ISO 5840-3(经导管)测试瓣膜性能
心脏瓣膜)、ISO 25539-1(心血管植入物)和ISO 10993 -1(生物相容性)。我们还将修改我们的
阀门制造能力符合FDA质量管理体系。目标3测试阀门,
绵羊体内模型。在急性试验以及10周和20周的慢性试验中,对瓣膜的有效性和安全性进行了试验。
Aim 4致力于整合PolyNova和阀门技术的监管和业务计划。
STTR第二阶段项目的组成部分是详细的商业化和监管计划,
在第二阶段计划的支持下,我们将把PolyNova从一个纯粹的研发商店转变为一个公司,
合格的医疗器械制造商-即具有完全符合cGMP、FDA的质量管理体系的机构
包括强大的设计控制流程。
上述目标的成功实现将导致主动脉瓣疾病治疗的突破,
提供负担得起的、长期的、微创的解决方案,
人口
项目成果
期刊论文数量(3)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Patient-specific in vitro testing for evaluating TAVR clinical performance-A complementary approach to current ISO standard testing.
- DOI:10.1111/aor.13841
- 发表时间:2021-04
- 期刊:
- 影响因子:2.4
- 作者:Kovarovic BJ;Rotman OM;Parikh P;Slepian MJ;Bluestein D
- 通讯作者:Bluestein D
Visions of TAVR Future: Development and Optimization of a Second Generation Novel Polymeric TAVR.
TAVR 未来的愿景:第二代新型聚合物 TAVR 的开发和优化。
- DOI:10.1115/1.4054149
- 发表时间:2022
- 期刊:
- 影响因子:0
- 作者:Kovarovic,Brandon;Helbock,Ryan;Baylous,Kyle;Rotman,OrenM;Slepian,MarvinJ;Bluestein,Danny
- 通讯作者:Bluestein,Danny
Mild Paravalvular Leak May Pose an Increased Thrombogenic Risk in Transcatheter Aortic Valve Replacement (TAVR) Patients-Insights from Patient Specific In Vitro and In Silico Studies.
轻度脊椎泄漏可能在经导管主动脉瓣置换(TAVR)患者特定体外和硅研究中的患者诊断中构成增加的血栓形成风险。
- DOI:10.3390/bioengineering10020188
- 发表时间:2023-02-01
- 期刊:
- 影响因子:0
- 作者:
- 通讯作者:
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DANNY BLUESTEIN其他文献
DANNY BLUESTEIN的其他文献
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{{ truncateString('DANNY BLUESTEIN', 18)}}的其他基金
Biomechanical Approaches and Technologies for Enhancing TAVR Outcomes
提高 TAVR 效果的生物力学方法和技术
- 批准号:
10201598 - 财政年份:2018
- 资助金额:
$ 59.43万 - 项目类别:
Biomechanical Approaches and Technologies for Enhancing TAVR Outcomes
提高 TAVR 效果的生物力学方法和技术
- 批准号:
10449331 - 财政年份:2018
- 资助金额:
$ 59.43万 - 项目类别:
A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement
用于经导管主动脉瓣置换的新型聚合物瓣膜
- 批准号:
9344868 - 财政年份:2017
- 资助金额:
$ 59.43万 - 项目类别:
A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement
用于经导管主动脉瓣置换的新型聚合物瓣膜
- 批准号:
10221033 - 财政年份:2017
- 资助金额:
$ 59.43万 - 项目类别:
A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement
用于经导管主动脉瓣置换的新型聚合物瓣膜
- 批准号:
9903032 - 财政年份:2017
- 资助金额:
$ 59.43万 - 项目类别:
Multiscale Modeling of Blood Flow and Platelet Mediated Thrombosis
血流和血小板介导的血栓形成的多尺度建模
- 批准号:
9032130 - 财政年份:2016
- 资助金额:
$ 59.43万 - 项目类别:
Multiscale Modeling of Blood Flow and Platelet Mediated Thrombosis
血流和血小板介导的血栓形成的多尺度建模
- 批准号:
9265504 - 财政年份:2016
- 资助金额:
$ 59.43万 - 项目类别:
Multiscale modeling of blood flow and clotting in cardiovascular devices
心血管设备中血流和凝血的多尺度建模
- 批准号:
8114454 - 财政年份:2011
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Multiscale modeling of blood flow and clotting in cardiovascular devices
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8016863 - 财政年份:2010
- 资助金额:
$ 59.43万 - 项目类别:
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