Statements (119)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:brand
gptkb:medical_devices |
| gptkbp:acquired_by |
gptkb:Abbott_Laboratories
|
| gptkbp:advances |
ongoing research and development
continuously evolving. |
| gptkbp:aims_to_improve |
patient outcomes
|
| gptkbp:approves |
gptkb:FDA
|
| gptkbp:benefits |
reduced recovery time
shorter recovery time |
| gptkbp:clinical_data_publication |
peer-reviewed journals
|
| gptkbp:clinical_trial |
gptkb:Tendyne_Medical,_Inc.
gptkb:2015 ongoing completed Phase III positive outcomes multi-center trials multiple sites worldwide positive outcomes reported over 100 patients Phase I, II, III trials Tendyne Clinical Trial independent monitoring board reduced hospital stay reduction in mitral regurgitation specific metrics evaluated |
| gptkbp:clinical_trial_endpoints |
safety and efficacy
|
| gptkbp:clinical_trial_exclusion_criteria |
severe comorbidities
|
| gptkbp:clinical_trial_inclusion_criteria |
symptomatic patients
|
| gptkbp:clinical_trial_results_publication |
published in medical journals
|
| gptkbp:clinical_trial_results_summary |
favorable outcomes reported.
|
| gptkbp:clinical_use |
integrated into cardiology practices
|
| gptkbp:collaborates_with |
gptkb:healthcare_professionals
|
| gptkbp:competitors |
gptkb:surgical_mitral_valve_replacement
gptkb:Edwards_Lifesciences other mitral valve devices |
| gptkbp:complications |
low risk
|
| gptkbp:customer_satisfaction |
high satisfaction rates
high reported levels |
| gptkbp:design |
self-expanding valve
|
| gptkbp:designed_for |
minimally invasive procedures
|
| gptkbp:developed_by |
gptkb:Tendyne_Medical
|
| gptkbp:develops |
transcatheter heart valves
|
| gptkbp:device_approval |
based on clinical evidence
based on clinical trials |
| gptkbp:device_approval_process |
rigorous evaluation
|
| gptkbp:device_design |
patient-centric
|
| gptkbp:device_innovation |
new valve design technology
|
| gptkbp:device_longevity |
designed for durability
|
| gptkbp:device_maintenance |
minimal required
|
| gptkbp:device_performance |
monitored post-implantation
|
| gptkbp:device_size |
various sizes available
|
| gptkbp:device_training |
available for healthcare providers
|
| gptkbp:durability |
long-term durability studies
|
| gptkbp:effective_date |
CE Mark approved
|
| gptkbp:eligibility |
specific criteria required
|
| gptkbp:events |
long-term follow-up studies
routine monitoring required |
| gptkbp:features |
self-expanding design
|
| gptkbp:feedback |
generally positive
|
| gptkbp:first_introduced |
gptkb:2017
|
| gptkbp:focuses_on |
heart valve replacement
|
| gptkbp:founded_in |
gptkb:2014
|
| gptkbp:funding |
gptkb:venture_capital
various sources |
| gptkbp:future_prospects |
focused on long-term outcomes
|
| gptkbp:headquartered_in |
gptkb:Minnesota
|
| https://www.w3.org/2000/01/rdf-schema#label |
Tendyne
|
| gptkbp:implantation_method |
transcatheter approach
|
| gptkbp:implantation_technique |
transfemoral access
|
| gptkbp:innovation |
gptkb:advanced_technology
unique anchoring system |
| gptkbp:invention |
patented technology
|
| gptkbp:is_a_platform_for |
transcatheter technology
|
| gptkbp:key_feature |
minimally invasive procedure
|
| gptkbp:key_opinion_leaders |
cardiologists
|
| gptkbp:launch_date |
gptkb:2018
|
| gptkbp:manufacturer |
gptkb:Tendyne_Medical,_Inc.
|
| gptkbp:market |
ongoing
ongoing studies |
| gptkbp:market_launch |
gptkb:2017
|
| gptkbp:market_position |
global
|
| gptkbp:marketed_as |
gptkb:United_States
|
| gptkbp:notable_technology |
radiopaque markers
|
| gptkbp:offers |
less invasive procedures
|
| gptkbp:partnerships |
medical institutions
|
| gptkbp:pathway |
breakthrough device designation
|
| gptkbp:patient_education |
available online
provided pre-procedure |
| gptkbp:patient_population |
varied age groups
patients with mitral regurgitation |
| gptkbp:price |
considered premium
|
| gptkbp:produces |
gptkb:medical_devices
|
| gptkbp:provides_guidance_on |
included in treatment guidelines
included in treatment protocols |
| gptkbp:publication |
multiple studies published
|
| gptkbp:recruitment |
based on echocardiographic assessment
careful assessment required high surgical risk patients |
| gptkbp:regulatory_compliance |
CE Marked
FDA approved based on safety and efficacy |
| gptkbp:safety_features |
generally safe
favorable |
| gptkbp:shipping_options |
transcatheter
|
| gptkbp:specialties |
interventional cardiologists
percutaneous |
| gptkbp:target_patient_group |
patients with mitral regurgitation
|
| gptkbp:training |
varies by experience
|
| gptkbp:training_programs |
available for physicians
available for surgeons |
| gptkbp:treatment |
improved quality of life
improved hemodynamics monitored post-implantation |
| gptkbp:type |
transcatheter heart valve
transcatheter mitral valve |
| gptkbp:type_of_insurance |
varies by provider
|
| gptkbp:used_for |
mitral valve replacement
|
| gptkbp:user_feedback |
generally positive
|