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Bioabsorbable Stents. The Ideal Scaffold properties and kinetics Jonathan Hill King’s College Hospital King’s Health Partners . BIOABSORBABLE STENTS Chairs: Carlo di Mario and Julian Gunn 11:25 The ideal scaffold – properties and kinetics Jonathan Hill 11:35 The current players

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bioabsorbable stents
Bioabsorbable Stents

The Ideal Scaffold

properties and kinetics

Jonathan Hill

  • King’s College Hospital
  • King’s Health Partners

BIOABSORBABLE STENTS

Chairs: Carlo di Mario and Julian Gunn

11:25

The ideal scaffold – properties and kinetics

Jonathan Hill

11:35

The current players

Adrian Banning

11:45

Early clinical results

Angela Hoye

12:05

Regulatory issues

Susanne Ludgate

12:10

Panel Discussion

transient biodegradable scaffold
TransientBiodegradable Scaffold
  • Building a skyscraper in Hong Kong with bamboo scaffold
slide4
REVASCULARISATION- As effective as a DES

Platform and Drug

RESTORATION- Restores natural vascular response—”Vascular restoration therapy”

Improved reendothelialisation and no long term inflammation,

Further intervention and non invasive imaging possible

RESORPTION- Transient

No permanent metallic implant.

The Ideal BioresorbableScaffold –

Properties and Kinetics The 3 Rs

properties and kinetics for a bioabsorbable device
Properties and Kinetics for a Bioabsorbable Device

Support

Full Mass Loss & Bioabsorption

Drug Elution

Mass Loss

Platelet Deposition

Matrix Deposition

Leukocyte Recruitment

Re-endothelialization

SMC Proliferation and Migration

Vascular Function

3

1

2 Yrs

6

Mos

Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.

phases of functionality
Phases of Functionality

Revascularization

Restoration

Resorption

Support

Full Mass Loss & Bioabsorption

Drug Elution

Mass Loss

Platelet Deposition

Matrix Deposition

Leukocyte Recruitment

Re-endothelialization

SMC Proliferation and Migration

Vascular Function

3

1

2 Yrs

6

Mos

Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.

slide7

Revascularization Phase (0 – 3 months)

Performance should mimic that of a metallic DES

Design Requirements:

  • Good deliverability
  • Minimum of acute recoil
  • High acute radial strength
  • Therapeutic agent delivered to abluminal tissue at a controlled rate
  • Excellent conformability
radial strength
Radial Strength

Radial Strength MSI Testing

(mmHg)

991

883

Cohort B

XIENCE V

Radial strength comparable to metal stent at T=0

Tests performed by and data on file at Abbott Vascular.

addressing vessel implant compliance mismatch
Addressing Vessel/Implant Compliance Mismatch

LESS

Conformable

Original PVA vessel curvature

MORE

Conformable

(permanent metallic stent)

(temporary implant)

Tests performed by and data on file at Abbott Vascular.

phases of functionality1
Phases of Functionality

Revascularization

Restoration

Resorption

Support

Full Mass Loss & Bioabsorption

Everolimus Elution

Mass Loss

Platelet Deposition

Matrix Deposition

Leukocyte Recruitment

Re-endothelialization

SMC Proliferation and Migration

Vascular Function

3

1

2 Yrs

6

Mos

Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.

slide11

Restoration Phase (3 months  Structural Discontinuity)

Transition from vessel scaffolding to discontinuous structure

Design Requirements:

  • Gradually lose radial strength
  • Struts must be incorporated into the vessel wall (strut coverage)
  • Become structurally discontinuous
  • Allow the vessel to respond naturally to physiological stimuli
poly lactide hydrolysis
Poly Lactide - Hydrolysis

PLA – Poly Lactic Acid

PLA

H2O

 Molecular Weight

Hydrolysis

Lactic Acid

O

O

Mass Loss

R

+

H2O

R

+

HO

R′

O

R′

OH

carboxylic acid

alcohol

Mass Transport

CO2 + H2O

Krebs Cycle

strut coverage absorb 6 month oct results
Strut Coverage: ABSORB 6-Month OCT Results

Strut Coverage – 6 Mos. F/U

1%

99%

N = 13 devices, 671 struts

Complete

Incomplete

Ormiston, J, et al. Lancet 2008; 371: 899-907.

mechanical conditioning
Mechanical Conditioning

Support

Full Mass Loss & Bioabsorption

Everolimus Elution

Mass Loss

Platelet Deposition - Thrombosis

Matrix Deposition - Remodeling

Leukocyte Recruitment - Inflammation

Re-endothelialization

SMC Proliferation and Migration

Vascular Function

Vascular Function

3

1

2 Yrs

6

Mos

mechanical conditioning1
Mechanical Conditioning

Vascular Function

Support

Gradual disappearance of supportive structure

Vessel recovers the ability to respond to physiologic stimuli

Shear stress & pulsatility

Tissue adaptation

Structure and functionality

mechanical conditioning2
Mechanical Conditioning

J Am Acad Orthop Surg, Vol 9, No 5, September/October 2001, 280-288.

Bioabsorbable Implants in Orthopaedics: New Developments and Clinical Applications

William J. Ciccone, II, MD, Cary Motz, MD, Christian Bentley, MD and James P. Tasto, MD

The use of bioabsorbable implants in orthopaedic surgical procedures is becoming more frequent. Advances in polymer science have allowed the production of implants with the mechanical strength necessary for such procedures. Bioabsorbable materials have been utilized for the fixation of fractures as well as for soft-tissue fixation. These implants offer the advantages of gradual load transfer to the healing tissue, reduced need for hardware removal, and radiolucency, which facilitates postoperative radiographic evaluation. Reported complications with the use of these materials include sterile sinus tract formation, osteolysis, synovitis, and hypertrophic fibrous encapsulation. Further study is required to determine the clinical situations in which these materials are of most benefit.

Bioabsorbable…implants offer the advantages of gradual load transfer to the healing tissue, …

Bioabsorbable orthopedic implants offer the advantage of gradual load transfer (mechanical conditioning) and improved healing versus stress shielding concerns seen with metallic implants

Ciccone, W. et al. J Am Acad Orthop Surg. 2001;9:280-288.

phases of functionality2
Phases of Functionality

Revascularization

Restoration

Resorption

Support

Full Mass Loss & Bioabsorption

Everolimus Elution

Mass Loss

Platelet Deposition

Matrix Deposition

Leukocyte Recruitment

Re-endothelialization

SMC Proliferation and Migration

Vascular Function

3

1

2 Yrs

6

Mos

Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.

porcine coronary safety study representative photomicrographs 2x
Porcine Coronary Safety Study:Representative Photomicrographs (2x)

BVS

1 month

1 year

4 years

3 years

2 years

6 months

CYPHER

1 month

6 months

3 years

4 years

1 year

2 years

Tests performed by and data on file at Abbott Vascular.

Photos taken by and on file at Abbott Vascular.

bvs minimal inflammation
BVS: Minimal Inflammation

4

3

2

1

0

3 Mo

6 Mo

12 Mo

18 Mo

24 Mo

36 Mo

Porcine Coronary Artery Model

Inflammation Score (0-4)

BVS associated Inflammation markedly less than Cypher

Benign bioabsorption with minimal inflammation observed beyond 1 year

Cypher

BVS

Inflammation score ≤ 1 = background

Tests performed by and data on file at Abbott Vascular.

slide20

Resorption Phase (Structural Discontinuity  Resorption)

Vessel is returned to a more natural state

Potential benefits:

  • Cellular/extracellular organization (vascular integrity)
  • Return of vascular function
  • Address current DES concerns
  • Late lumen enlargement
  • Durability of clinical outcomes
slide21

Resorption Phase (Structural Discontinuity  Resorption)

Restoration of vascular integrity in porcine model

1 month

36 month

a-actin stain

At 36 months, SMCs are well organized and phenotypically contractile

Tests were performed by and data are on file at Abbott Vascular.

slide22
REVASCULARISATION

As effective as a DES

RESORPTION

Transient

RESTORATION

Restores natural vascular response

The Ideal Scaffold- Properties and Kinetics

acknowledgements
Acknowledgements
  • Richard Rapoza
  • Tony Gershlick
  • Jonathan Hill jmhill@nhs.net
slide24

“Modernity is the transient, the fleeting;it is the one half of art, the other, the other being the eternal and the immovable”Les Fleurs du Mal 1857 Baudelaire 1821- 1867