ep passion crn - mdepinet.orgmdepinet.org/wp-content/uploads/ep-passion-crn.pdf · 2019-12-18 ·...

Electrophysiology Predictable and Sustainable Implementation of National Registries: EP PASSION Li Wang, PhD, MBA, MS, Daniel Canos, PhD, MPH, Hetal Patel, MS, Jessica Paulsen, BS, Kimberly Selzman, MD, Benjamin Eloff, PhD, Danica Marinac-Dabic, MD, PhD, MMSc, FISPE. Office of Surveillance and Biometrics & Office of Device Evaluation, Center for Devices and Radiological Health U.S. Food and Drug Administration, Silver Spring, MD. 20903 The Regulatory Gap Traditional Post-Approval Inefficiencies • Stand-Alone Study • Pace and Enrollment Difficulty • Prolonged Completion Time • Next Generation on market before “Lessons Learned” Traditional Post-Market Study Cost • ~$10 million in traditional PAS studies • Potential 40-60% savings with registry based surveillance EP PASSION Objectives EP PASSION is focused on implantable cardioverter defibrillator system leads and pulse generators and cardiac resynchronization therapy left heart leads. A RWE- based approach can streamline post-approval studies by: • Reducing Cost • Reduce time to enrollment completion • Reduce loss to follow-up • Provide timely answers to post-market questions Objective 1: • Transition long-term direction patient follow-up assessment in current post- approval studies (PAS) towards a real world evidence approach (RWE). Objective 2: • Develop sustainable mechanism to collect long-term chronic performance of new and substantially modified pacing and defibrillation leads. EP PASSION Components Phase II: ID Phase III: Develop New/Modify Phase IV: Develop Linked Approach EP PASSION Phased Approach EP PASSION Post-Approval Study Transition Extant Registry/EHR Claims Remote Monitoring Implant & Periprocedural Data Annual Follow-Up Annual Follow-Up Traditional PAS Transition of Ongoing PAS ~10 Years <10 Years Novel RWE PAS <10 Years EP PASSION Influence The shift towards RWE in the EP field has already begun…. • FDA recently approved the Boston Scientific S-ICD Post-Approval Study with no pre-market data. The powered, hypothesis-driven study incorporates the ACC NCDR registry, Boston Scientific’s LATITUDE NXT Patient Management System, CMS/Truven claims, and the National Death Index. EP PASSION Partners EP PASSION Timeline

Upload: others

Post on 11-Jun-2020

0 views

Category:

Documents

0 download

Report

Download

Embed Size (px):

TRANSCRIPT

Page 1: EP PASSION CRN - MDEpiNet.orgmdepinet.org/wp-content/uploads/EP-PASSION-CRN.pdf · 2019-12-18 · EP PASSION Phased Approach EP PASSION Post-Approval Study Transition Extant Registry/EHR

Electrophysiology Predictable and Sustainable Implementation of National Registries: EP PASSION

LiWang,PhD,MBA,MS,DanielCanos,PhD,MPH,HetalPatel,MS,JessicaPaulsen,BS,KimberlySelzman,MD,BenjaminEloff,PhD,Danica Marinac-Dabic, MD,PhD,MMSc,FISPE.

OfficeofSurveillance and Biometrics &Office ofDevice Evaluation,CenterforDevices and RadiologicalHealthU.S.Foodand Drug Administration, SilverSpring,MD.20903

TheRegulatoryGapTraditionalPost-ApprovalInefficiencies• Stand-AloneStudy• PaceandEnrollmentDifficulty• ProlongedCompletionTime• NextGenerationonmarketbefore“LessonsLearned”TraditionalPost-MarketStudyCost• ~$10millionintraditionalPASstudies

• Potential40-60%savingswithregistrybasedsurveillance

EPPASSIONObjectivesEPPASSIONisfocusedonimplantablecardioverterdefibrillatorsystemleadsandpulsegeneratorsandcardiacresynchronizationtherapyleftheartleads.ARWE-basedapproachcanstreamlinepost-approvalstudiesby:

• ReducingCost• Reducetimetoenrollmentcompletion• Reducelosstofollow-up• Providetimelyanswerstopost-marketquestions

Objective1:• Transitionlong-termdirectionpatientfollow-upassessmentincurrentpost-

approvalstudies(PAS)towardsarealworldevidenceapproach(RWE).Objective2:• Developsustainablemechanismtocollectlong-termchronicperformanceof

newandsubstantiallymodifiedpacinganddefibrillationleads.

EPPASSIONComponents

Phase II: ID & Assess

Phase III: Develop New/Modify

Phase IV: Develop Linked Approach

EPPASSIONPhasedApproachEPPASSIONPost-ApprovalStudyTransition

ExtantRegistry/EHR

Claims RemoteMonitoring

Implant&Periprocedural

DataAnnual

Follow-Up

AnnualFollow-Up

TraditionalPAS

TransitionofOngoingPAS

~10Years

<10Years

NovelRWEPAS<10Years

EPPASSIONInfluenceTheshifttowardsRWEintheEPfieldhasalreadybegun….• FDArecentlyapprovedtheBostonScientificS-ICDPost-ApprovalStudy

withnopre-marketdata.Thepowered,hypothesis-drivenstudyincorporatestheACCNCDRregistry,BostonScientific’sLATITUDENXTPatientManagementSystem,CMS/Truven claims,andtheNationalDeathIndex.

EPPASSIONPartners

EPPASSIONTimeline

EP-978A3, EP-808AW/AB/AR, EP-10VA, EP-708Adl.epson.jp/products/colorio/EWPG2015_A4A3.pdfEP-978A3、EP-808AW/AB/AR、 EP-10VA、EP-708A Web WebサイトのURLを入力して、プリン

EP-BHC8-WA EP-BHC10-WA EP-BHC12-WA EP-BHC16 …€¦ · EP-CC9S-GS EP-CC12-GS EP-CC16-GS EP-FLCC EP-ST770 9 oz. Compostable Cold Cup 12 oz. Compostable Cold Cup 16 oz. Compostable

Adwood-ceAdwood-cehisa Schematics and Manual Ep-7 Ep-8 Ep-9 hisa Schematics and Manual Ep-7 Ep-8 Ep-9 Small

iütTJ;:ü,nr#n;;Ii* · ollox€sap Ie: eJqos outroJul etueJ 'elleroJ ep ep peplues ep ulunf 'tgg l ep olso8e ¿ ¡ oEunuop ¡ep euo¡drued ep lercgo upalog ¡e oluotueldns.tgg 1

PCO16 Day One Steven Hochanadel EP Energy - LBCG · 3 EP Energy ALTAMONT WOLFCAMP EAGLE FORD At EP Energy, we have a passion for ﬁnding and producing the oil and natural gas that

FPL Energy Point Beach, LLC, 6590 Nuclear Road, Two Rivers ...EP 1.0 EP 2.0 EP 3.0 EP 4.0 EP 5.0 EP 6.0 EP 7.0 EP 8.0 EP 9.0 ... 26' PAB 1 (2)RE-109 Failed letter referencing Reg Indication

64 ep 74 ep SERIES 4 ALPIN 84 ep 84 ep Pro 94 ep 104 ep · 2017. 11. 28. · ZF Quality – made in Austria The GEOTRAC 64 ep and 74 ep are equipped with a ZF Steyr fully synchronous

Pacific· Gas .and El'ecmc Company;to · ep rb-1 ep rb-2 ep rb-3 ep rb-4 ep rb-5 ep rb-8* ep rb-9 ep rb-10 ep rb-11 ep rb-12 ep rb-14 ep rb-14a ep rb-15 ep rb-16 ep r-2 ep r-3 ep

Ammeraal Beltech Modular · 2016.10.31 uni Light EP C uni Light EP 8,5 uni Light EP 18 uni Light EP 22 uni Light EP 22% Fine-meshed uni Light EP 28 uni Light EP 33 uni Light EP 46

TMD Background History of TMJ Implants - mdepinet.orgmdepinet.org/wp-content/uploads/05A-T_Cowley_Presentation_Friday... · Manifestation of TMD Pain in the chewing muscles of the