Calcified Cephalohematoma: Classification, Indications for Surgery ...
Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility:...
Transcript of Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility:...
Phoenix 500: Interim Results from the Phoenix Registry
Miguel Montero-Baker, MDAssociate Professor
Division of Vascular Surgery and Endovascular Therapy
Baylor College of Medicine
Houston, Texas
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Disclosure
Speaker name:
Montero Baker
I have the following potential conflicts of interest to report:
Consulting
Dr. Montero-Baker has been compensated by Philips for his/her
services in preparing and presenting this material for Philips’ further
use and distribution.
The opinions and clinical experiences herein are specific to the featured physicians and the
featured patients and are for information purposes only. The results from their experiences may
not be predictive for all patients. Individual results may vary depending on a variety of patient-
specific attributes and related factors. Nothing in this presentation is intended to provide specific
medical advice or to take the place of written law or regulations.
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Phoenix Atherectomy System
Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified arteries, for lesions both above and below the knee2
Center mass cutter: Clears tissue in a way that may reduce potential trauma to the vessel. Phoenix cutter head allows debulked tissue be continuously captured, resulting in a <1% rate of distal embolization3
Cut, capture and clear mechanism of action: Front cutter clears tissue, blades continuously capture debulked material, which is removed by the Archimedes screw.
Cut:
Front cutter
clears tissue
Capture:
Blades
designed for
continuous
capture
Clear:
Archimedes
screw clears
debulked
tissue
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Phoenix 500: Study Overview
Study ObjectiveEvaluate the short and long-term clinical outcomes of patients treated with
Phoenix atherectomy system for peripheral artery disease (PAD)
Interim Results: Acute and 30 day Follow up(12 month follow-up in CLI patients pending)
Study Design:Prospective, observational study
N= 500 subjects (from 17 US centers)
Follow-up: 30 Days; and 12 months (for CLI patients only)
Phoenix sizing:
1.8mm (5F), 2.2mm (6F), 2.4mm (7F)
Primary endpoints
Safety: Device related complication
Efficacy: Procedural success
Secondary endpoints
TLR, TVR, Target limb amputation
Changes in ABI and WIfI
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Baseline and Lesion Characteristics
Baseline characteristics comparable overall between CLI and all patients
CLI patients had higher rate of DM, BTK and severely calcified lesions©2019 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. Approved for external distribution. D048418-00 012019
Primary Efficacy Endpoint
Full cohort show high procedural success rates with CLI patients exhibiting greater technical and procedural
success ratesTechnical success = acute debulking, achieving a post-Phoenix (prior to any adjunctive therapy) residual diameter stenosis of ≤50%.
Procedural Success = achievement of a final target lesion(s) residual stenosis of ≤30% after treatment with Phoenix and any other adjunctive
therapy
NR= Not reported
Atherectomy Device Success Rates
Atherectomy Device Procedural Success Technical Success
Phoenix 500
All comers: 96.8%(484/500)
All comers: 61.6% (308/500)
CLI: 97.3% (254/261)
CLI: 67.4%(176/261)
Directional Atherectomy Devices 1-4
89.1 to 100% 97%
Rotational Atherectomy Devices 5-10
NR 76%
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Primary Safety Endpoint
The rate of complications post Phoenix Atherectomy are generally below 1% and well within range of complications
associated with atherectomy devices©2019 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. Approved for external distribution. D048418-00 012019
Secondary Endpoints: Full Cohort and CLI
Full cohort: N=465
Endpoint 30 Day
TLR 1.3% (6)
Major Amputations 0%
CLI cohort
Endpoint 30 Day (N=237)
12 Months (N=123)
TLR 1.7% 17.1% (21)
Major Amputations
0% 8.1% (10)*
UnplannedAmputations
2.1% (5)(minor)
13.8% (17)
• No Major Amputations at 30 Days
• Low rates of TLR at both 30 Days
(Full cohort) and 12 months (CLI
group)
• Lower rate of major amputations
for RCC 5 and RCC 6 patients vs
Liberty 360 trial
Rutherford Classification
PhoenixRegistry
Liberty 360
RCC 5 2.4% 4.0%
RCC 6 5.7% 18.7%
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*12m Amputation Details3 had Baseline RCC 57 had Baseline RCC 6
Improvements in Rutherford Status in CLI
Patients, Post Phoenix Atherectomy
CLI patients exhibit acute Rutherford score improvements, with greater than 67% of patients improving by a score of greater than 1
@ 12 months follow-up ©2019 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. Approved for external distribution. D048418-00 012019
Improvements in WIfi Classifications in All-
Comers and CLI Patients
18.6% of CLI patients exhibit WIfi classification improvements, with greater than 94% of patients classified as low or very low @ 12
months follow-up ©2019 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. Approved for external distribution. D048418-00 012019
Conclusions Phoenix Atherectomy System continues to be a safe and
effective endovascular solution for the treatment of peripheral arterial disease.
Interim results reveal improved efficacy and durable improvements in the CLI population
Acute Rutherford score improvements in CLI patients are consistent with general study population and continue in the long-term
Phoenix 500 shows promising benefits for the CLI population
Phoenix Atherectomy System continues to be a viable solution in the treatment paradigm for all spectrums of PAD (Rutherford 2-6) which lead to significant clinical improvements
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Phoenix 500: Interim Results from the Phoenix Registry
Miguel Montero-Baker, MDAssociate Professor
Division of Vascular Surgery and Endovascular Therapy
Baylor College of Medicine
Houston, Texas
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