CASE 0:19-cv-01760-PJS-TNL Document 189-31 Filed 12/06/19 Page 1 of 4
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`4 Vascular
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`SOLUTIONS
`
`Memorandum
`
`To:
`From:
`Date:
`Re:
`
`Deborah Neymark
`Rose Griffith
`8/26/05
`Weekly Staff Meeting
`
`Pocket Study
`o PMA Status - No change
`o Secured final determinations for outstanding events
`o Ongoing discussion with statistician re: safety analysis
`o All remaining data and corrections entered into DB
`o Safety data re-exported to Rich H (8/25/05) to perform supplementary
`analysis
`o Current target submission date Sept. 19th (Mon)
`o Closure study report - No change (pending safety analysis)
`o Outstanding analyses
`• Final Primary and Secondary Safety (pending CEC)
`• Covariate analysis
`• Secondary Effectiveness
`• Pt. Satisfaction - At Discharge
`• Duration of procedure (update pending)
`• Protocol deviations
`o IFU and SSED - Complete except for Safety Results
`o TCT (poster category): Status pending site response
`o AHA (Late Breaking Clinical Trials category): Not accepted
`o Milestone: MS preparation for submission to peer reviewed journal
`o Primary Author: Dr. Slotwiner
`o Target date for submission: Nov. 30th 2005
`• Journals for consideration
`• Journal of Cardiovascular Electrophysiology (optimal)
`• American Heart Journal
`• American Journal of Cardiology
`• Clinical Cardiology
`• Dr. Slotwiner to provide input for target journal
`
`D-Stat Dry
`Clinical Trial: D-Stat Dry in Diagnostic Patient (multi-center)
`o Study Closure Report
`o Analysis received from statistician 8/9 - 9/12
`o Closure report (draft) completed 8/13
`o Outstanding item: Poolability analysis (should be received next week)
`o Once poolability received will update report and circulate for sign-off
`• TCT (oral presentation category): Not accepted
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`Confidential - Attorneys' Eyes Only
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`VSIMDT00030135
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`EXHIBIT 31
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`Page 1
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`Teleflex Ex. 2040
`Medtronic v. Teleflex
`IPR2020-00126
`
`

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`CASE 0:19-cv-01760-PJS-TNL Document 189-31 Filed 12/06/19 Page 2 of 4
`August 26, 2005
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`o Consider abstract submission to "All About Jazz" — New Orleans 2006
`o Biggest Vascular meeting
`• Large attendance — solid, strong peripheral program
`o Milestone: MS preparation for submission to peer reviewed journal
`o Primary Author: Dr. Hallack
`o Target date for submission: Nov. 30th 2005
`• Journals for consideration
`• Catheterization and Cardiovascular Interventions
`• Dr. Hallack concurs with CCI submission
`
`Clinical Trial: D-Stat in the Interventional Patient (Chambers - single center)
`o Total randomized enrollment: 27/50 subjects or 54%
`• Control: 14 pts
`O Investigation: 13 pts
`o TCT (oral presentation): Not accepted
`o Single center feasibility study in patients receiving Angiomax (sheath pull of 2 hours
`post turning off Angiomax), 6 Fr Interventional population
`
`3 x 3: St. Frances - Shakopee MN (Status pending)
`O No As
`o Spoke with Cindy D. - 40 pts. treated (possibly more). She's working on data
`collection - set expectation that all data would be ready and available by end of July
`to begin analysis/write-up.
`
`D-Stat Dry- In Vitro Comparative Analysis of 6 Competitive Products
`o TCT (poster category): Not accepted
`O Consider Biomaterials conference 2006 — will need to assess sanction status
`o Consider for MS publication — Biomaterials journals?
`o Confirmed abstract submission to TCT (poster - Lead author: Dr. Rao)
`O Evaluates whole blood, Non-woven pad, CloSur Pad, D-Stat Dry, Hemaderm,
`ChitoSeal, Neptune Pad, & Syvek
`
`D-Stat Dry- Arterial Closure Devices - Institution Sponsored: Borgess Medical
`Center
`O Obtained study protocol, ICF and CRFs
`o Reviewed and prepared study summary
`o Forwarded to Statistician for comment on sample size assumptions
`O No other updates — Carol on vacation this week
`
`Vari-Lase (US)- Publication
`O Dr. Michael T. McCormick - FL No
`O 1st podiatrist in US to achieve approval to include procedure in scope of practice
`O Recently purchased (May) his own console
`O He is preparing a series of 3 articles for the FL Podiatric Medicine Magazine on EVLT
`o Offered MS assistance 2 weeks ago - recently forwarded images for initial publication
`(LE anatomy, US, etc.)
`o Secured his Certificate of Training
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`2
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`Confidential - Attorneys' Eyes Only
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`VSIMDT00030136
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`EXHIBIT 31
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`Page 2
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`Teleflex Ex. 2040
`Medtronic v. Teleflex
`IPR2020-00126
`
`

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`CASE 0:19-cv-01760-PJS-TNL Document 189-31 Filed 12/06/19 Page 3 of 4
`August 26, 2005
`
`Radial Study - Spain, Dr. Goincolea
`o No - no responses from site (followed-up 8/25)
`O Garnered update from Bill Rutstein on current status of project
`o Contacted Teresa Mestre (IZASA Distributor - Clinical) to introduce myself, etc.
`o Confirmed - Will use 3501 product line for study (possibly available in Oct.)
`o Recently received CE Mark in Spain - now time to initiate trial
`O Should require very little VSI Clinical support (per DN)
`
`Thrombin Replacement
`O Pre-IDE submission packet forwarded to FDA
`o Assessing 24 current standards (IDE, IND, ICH...) for applicability to trial
`conduct
`
`Sealix
`O ANS Abstract book available October / presentation determinations to be made Aug.
`31 st
`o Meeting dates: Nov 10th - 13th
`
`D-Stat Flowable
`Dr. Kirsch @ Roxborough Hosp. Phily, PA - PUBLICATION INITIAVE ONLY:
`O No change
`o Dr. Kirsh - minor comments received
`o Gwen met with Dr. Kirsch (Oct. 7th) to discuss revisions
`o Revising as 3 page "letter to the editor" format and will resubmit to JVIR
`O In a paracentesis application
`
`Duett
`Dr. Kirsch @ Roxborough Hosp. Phily, PA:
`o No change
`o Need image text from Dr. Kirsch prior to manuscript submission
`O MS formatted for CVIR
`O In a UAE application
`
`PRO-MI IDE Study
`O Deborah met with Duke personnel 8/11-12
`o Protocol forwarded to Dr. Krucoff 8/3/05 for input
`O Need to assign Reg. support responsibility for IDE
`O Meeting scheduled with Duke 8/11/05
`O See previous updates for past details
`
`Literature Reviews
`- TR1159 Catheters in Coronary Application
`o Gwen completed for Langston, Twinpass and Skyway
`o Rose added Guideliner OTW and Guideliner RX
`o Circulated for sign-off 8/25
`- Laser therapy for RF users
`Nancy has requested a ML piece (white paper) comparing Endovenous
`laser and RF
`
`3
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`Confidential - Attorneys' Eyes Only
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`VSIMDT00030137
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`EXHIBIT 31
`
`Page 3
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`Teleflex Ex. 2040
`Medtronic v. Teleflex
`IPR2020-00126
`
`

`

`CASE 0:19-cv-01760-PJS-TNL Document 189-31 Filed 12/06/19 Page 4 of 4
`August 26, 2005
`
`- Update white paper (Mark's) for laser treatment
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`Vari-Lase German Experience:
`O FEKI Annual Report (Frieburger) remains overdue
`O Rose notified FEKI on 10/22/04 of delay in submission
`O Previously granted 2 month extension for annual interim report
`O Deborah completed site visits (Esser Tues. 8/17 & Rudofsky 8/18)
`O German experience: CA (FEKI) annual approval due June 23rd.
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`Confidential - Attorneys' Eyes Only
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`VSIMDT00030138
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`4
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`EXHIBIT 31
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`Page 4
`
`Teleflex Ex. 2040
`Medtronic v. Teleflex
`IPR2020-00126
`
`