Initial experience with a new3F compatible microstentfor BTK revascularization

Robert E. Beasley, MD, FSIR, FSCAIDirector of Vascular/Interventional Radiology & Vein Treatment CenterDirector of Wound Healing CenterMount Sinai Medical CenterMiami Beach, FL

Abbott

BSCI

Cardinal Health/Cordis

Cook Medical

CR BARD/Becton Dickinson

CSI

Endologix

• Inari

• Medtronic

• Micro Medical Solutions

• Philips/Volcano/Spectranetics

• Penumbra

• Terumo/Bolton

• WL Gore

DISCLOSURES

Consultant/Medical Advisory Board

Critical Limb Ischemia

• CLI is caused by multilevel and/or isolated infrapoliteal arterial disease1

Primary goals of treatment include limb preservation, wound healing, and relief of ischemic rest pain

• Endovascular therapies well established above the knee (DCB, BMS, DES)

• Current options BTK are limited to PTA as the primary endovascular approach2

1 Mustapha et al. PRIME Registry Interim Analysis Vasc Disease Mgmt 20172 Razavi J Vasc Interv Radiol 2014

Challenges in treating BTK disease

• Increasingly complex lesions BTK not suited to PTA alone• Significant recoil occurs post-PTA in up to 97% of cases3

• PTA alone fails to attain <30% RS in up to 42% of cases4

• Dissections occur in 20-30% of cases, often underreported due to small caliber of vessels2,5,6

• Off-label use of balloon-expandable coronary DES only bailout option– Data shows good results, limited to short, proximal lesions

– Limitations to stent design Low flexibility

Limited stent lengths

Not able to use in areas of compression

3 Baumann F J Endovasc Ther 2014 5 Fanelli J Cardiovasc Surg 20144 Scheinert J Am Coll Cardiol 2012 6 Zeller J Am Coll Cardiol 2014

Micro Medical Solutions MicroStent®

NOTE: The MicroStent® is limited to Investigational use in the US.

The MicroStent® has CE mark and is commercially available in select OUS markets.

Thin strands designed for optimal vessel apposition and smooth, laminar flow

Proprietary platinum core design allows for visualization under ultrasound

Woven nitinol self-expanding stent designed to conform to the challenging anatomy of BTK

Deploys from ultra-low profile 3.2F delivery system, allowing for flexibility in access choice (including tibiopedal access)

Micro Medical Solutions MicroStent®

Stent Diameters

(mm)

Stent Lengths (mm)

15 25 40 60

3.0 X X X X

3.5 X X X X

4.0 X X X X

4.5 X X X X

Pre-dilate

Size 1:1

Position

Deploy

Post-dilate

1

2

3

Micro Medical Solutions MicroStent®

5

4

MicroStent® US Feasibility Study

Design Prospective, single-arm study evaluating acute safety and efficacy outcomes

Primary Endpoints Primary Patency at 30 daysFreedom from MALE + POD at 30 days

Principal Investigator Robert E. Beasley, MD, FSIR, FSCAIDirector of Vascular/Interventional Radiology & Vein Treatment CenterDirector of Wound Healing CenterMount Sinai Medical Center - Miami Beach, FL

Number of Subjects/Sites 15 Subjects at 3 sites

Follow-up Clinical assessment and DUS at 14 days, 1 month, 3 months, 6 months,12 months, 24 months and 36 months

Key inclusion • Up to 3 focal lesions (≤5cm) with an RVD between 2.5mm and 4.5mm• Rutherford 4-5• At least single vessel with runoff to foot• Successful treatment of inflow and clinically significant non-target

infrapopliteal lesions

Access • Retrograde (40cm delivery system)

Baseline Subject Characteristics

Age (yrs) Mean 69.6

Female 20.0% (3/15)

Male 80.0% (12/15)

BMI (kg/m²) Mean 29.3

Smoking History

Current smoker 26.7% (4/15)

Former smoker 33.3% (5/15)

Non-smoker 40.0% (6/15)

Diabetes Mellitus 60.0% (9/15)

History of CAD 33.3% (5/15)

History of Peripheral Intervention 66.6% (10/15)

History of Amputation 6.6% (1/15)

Rutherford Category

3 6.6% (1/15)

4 86.6% (13/15)

5 6.6% (1/15)

Target Limb ABI Mean ± SD 0.73 ± 0.23Target Limb TBI Mean ± SD 0.49 ± 0.77

Core Lab Baseline Lesion Characteristics

Characteristics Lesions (N=19)Target Limb Side (Subject Level)

Left 53.3% (8/15)

Right 46.7% (8/15)

Target Limb Vessel (Subject Level)

Anterior Tibial 60% (9/15)

Peroneal 13.3% (2/15)

Posterior Tibial 26.7% (4/15)

Tibial-peroneal trunk 6.7% (1/15)

Type of Lesion

De Novo 94.7% (18/19)

Restenotic 5.3% (1/19)

Target Lesion RVD (mm) Mean ± SD 3.1 ± 0.3

Target Lesion % Diameter Stenosis Mean ± SD 94.0% ± 6.5%

Target Lesion Length (mm) Mean ± SD 42.1 ± 18.7

Min, Max (8.66 – 120.12)

Calcification

None/Mild 63.2% (12/19)

Moderate 36.8% (7/19)

Severe 0% (0/19)

Broad anatomic distribution

Severe stenosis & CTOs

Long Lesions

Technical SuccessSubjects with:

No Stent Implanted 6.7% (1/15)

One Stent Implanted 73.3% (11/15)

Two Stents Implanted 20.0% (3/15)

Three Stents Implanted 0% (0/15)

More than Three Stents Implanted 0% (0/15)

Technical Success 1 94.4% (17/18)

Core Lab Reported Deployment Success 2 100%

1 Successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter

2 Core Lab assessment of lesion coverage, placement at intended target site(s)

ADJUDICATED PRIMARY SAFETY ENDPOINT

Freedom from Primary Safety Endpoint 100% (14/14)

Major Adverse Limb Events 0% (0/14)

Major Target Limb Amputation 0% (0/14)

Major Target Limb Reintervention 0% (0/14)

Perioperative Death 0% (0/14)

ADJUDICATED PRIMARY EFFICACY ENDPOINT

Effectiveness Measures within 14 Days

Primary Patency Endpoint 91.7% (11/12)

Freedom from Occlusion *Event not yet adjudicated 91.7% (11/12)

Freedom from Clinically Driven Target Lesion Revascularization 100% (12/12)

Effectiveness Measures within 30 Days

Primary Patency Endpoint 91.7% (11/12)

Freedom from Occlusion *Event not yet adjudicated 91.7% (11/12)

Freedom from Clinically Driven Target Lesion Revascularization 100% (11/12)

*Per Protocol Population

SECONDARY EFFICACY DATA

BASELINE 30 DAYS POST-INDEX PROCEDURE

Rutherford Category0 0% (0/15) 78.6% (11/14)1 0% (0/15) 7.1% (1/14)2 0% (0/15) 0% (0/14)3 6.6% (1/15) 14.3% (2/14)4 86.6% (13/15) 0% (0/14)5 6.6% (1/15) 0% (0/14)6 0% (0/15) 0% (0/14)

WIQ ScoreMean ± SD 0.24 ± 0.22 0.48± 0.35Median 0.19 0.54Min, Max (0.00 – 0.88) (0.00-1.00)

EQ-5DMean ± SD 0.73 ± 0.23 0.79± 0.16Median 0.82 0.81Min, Max (0.18 - 1.00) (0.40-1.00)

Incredible improvement in RCC

Improvement in patient health outcomes

MSMC - Ostium of AT

Baseline Runoff Final RunoffDeployment

2016MicroGuide Catheter and MicroBalloon receive CE Mark

MicroGuide Catheter and MicroBalloon receive 510k clearance

2017

MicroStent receives CE Mark

2018MicroStent Feasibility Study

2019

Design Prospective randomized multicenter clinical trial consisting of two arms; onearm treated with PTA + MicroStent® and one arm treated with PTA alone

Primary Endpoints Primary Patency at 6 monthsFreedom POD + MALE at 6 months

Principal Investigator Robert E. Beasley, MD, FSIR, FSCAIDirector of Vascular/Interventional Radiology & Vein Treatment CenterDirector of Wound Healing CenterMount Sinai Medical Center - Miami Beach, FL

Number of Subjects/Sites 177 subjects at up to 25 sites in US

Follow-up Clinical assessment and DUS at 30 days, 3 months, 6 months, 1 year,2 years and 3 years

Key inclusion • Up to 3 focal lesions (≤12cm) with an RVD between 2.5mm and 4.5mm• Rutherford 3-5• Target vessel outflow with runoff to foot• Successful treatment of inflow and clinically significant non-target

infrapopliteal lesions

Access • Retrograde (40cm delivery system)• Antegrade (120cm delivery system)

MSMC Multi-Disciplinary Peripheral Team

Have questions, contact us (305) 674-2071

– Robert E. Beasley, MD, FSIR, FSCAI

• Bbeaz@aol.com

– Timothy E. Yates, MD

• Timothy.Yates@msmc.com

– Brandon P. Olivieri, MD

• Brandon.Olivieri@msmc.com

– Christian O. Koelbl, MD

• Koelblco@gmail.com

Students are welcome to rotate with us.

@SOBE_Vascular #CLIFighters

THANK YOU!

Initial experience with a new3F compatible microstentfor BTK revascularization

Robert E. Beasley, MD, FSIR, FSCAIDirector of Vascular/Interventional Radiology & Vein Treatment CenterDirector of Wound Healing CenterMount Sinai Medical CenterMiami Beach, FL