Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility:...

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Phoenix 500: Interim Results from the Phoenix Registry Miguel Montero-Baker, MD Associate Professor Division of Vascular Surgery and Endovascular Therapy Baylor College of Medicine Houston, Texas ©2019 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. Approved for external distribution. D048418-00 012019

Transcript of Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility:...

Page 1: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 2: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 3: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 4: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 5: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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

Page 6: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 7: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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

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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

Page 9: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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

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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

Page 11: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 12: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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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Page 13: Phoenix 500: Interim Results from the Phoenix Registry · Phoenix Atherectomy System Versatility: Phoenix effectively treats a broad range of tissue types, from soft plaque to calcified

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