initial experience with a new 3f compatible microstent for ... · bms, des) • current options btk...
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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
– Timothy E. Yates, MD
– Brandon P. Olivieri, MD
– Christian O. Koelbl, MD
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