History of Device Development: Past, Present and Future

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Golden Rules
Device or procedure must be simple to apply an can be adopted by the average practitioner Invention addresses an otherwise unmet clinical need Device regulatory path is associated with a reasonable chance for success in an otherwise well defined study with a finite sample size

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999

2000 2002 2003 2004 2005 2006

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

16

History of Interventional Cardiology

1977

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Coronary Angioplasty (PTCA) Andreas Gruntzig

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Directional Coronary Atherectomy (DCA)

John Simpson

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Rotational Atherectomy (PTCRA) David Auth

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988

1989
Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Coronary Stenting Julio Palmaz

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989

1997

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

In- Stent Restenosis

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Brachytherapy

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999

2000
Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Drug Eluting Stents

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Event-Free Survival at Two Years following procedure

100 90

92%
Sir-MACE 76% Ctl-MACE

Freedom from 70 events (%) 60

50 0 120 240 360 480 600 720

80

Days after initial procedure

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

ARTS I: Three-year outcome after Stenting vs. CABG for the Treatment of Multivessel Disease

.
% Survival

100 99 98 97 96 95 94 93 92 91 90 0 120 240 360 480 600 720 840 960 1080 1200

Stent

CABG

Days since randomization

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Van Domburg, et al., Circ. 2004:109, 1114-20

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999 2000

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

2002

Percutaneous Treatment of Carotid Artery Stenosis

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Aortic Valve Therapy Alain Cribier

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Valve Therapy Edwards LifeSciences

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

The CoreValve Revalving System Self-Expanding Support Frame

Self-expanding Nitinol multi-level frame Porcine pericardium Tissue Valve

Disposab le Loading System Delivery Catheter

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

18 French

12 F

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999 2000

2002

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

2003

Percutaneous Mitral Valve Repair

Coronary Sinus Annuloplasty

Edge-to-Edge Repair

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Coronary Sinus Annuloplasty Edwards LifeScience

Sliding Knob Handle

Location of Implant (Internal) Bridge

Proximal Anchor

Distal Anchor

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Mitral Valve Edge-to-Edge Repair

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999

2000 2002 2003

2004

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Atrial fibrillation is a major source of cardiogenic embolism-related stroke

500,000 strokes per year AHA estimates that 15 20% of strokes/year are related to AF

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Source: Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 198

WATCHMAN Device

160 PET fabric

Device available in various sizes:

21, 24, 27, 30 and 33 mm
(diameter)

Device diameter is measured across face of device Device Length = Device Diameter
Barbs

Frame: Nitinol (shape memory)

Contour shape accommodates most LAA anatomy Barbs engage the LAA tissue

Fabric Cap: Polyethyl terephthalate (PET) Fabric

Prevents harmful emboli from exiting during the healing process
Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Left Atrial Appendage Closure

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999

2000 2002 2003 2004

2005
Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

The Next Frontier in Coronary Stenting

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Treating Bifurcation Lesions

Limitations of Current DES
Stents are tubular structures
not intended for Y-shaped anatomy

Side branch jailing Limited ostial coverage (Gaps) Technically demanding Multiple layers of metal Increasing risk of thrombosis Myriad of Techniques

Gap Multiple Layers

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

The TAXUS PetalTM

B s nS ie tificC ro o tio o to c n o p ra n
Delivery System Advantages Side Branch wire lumen aids in alignment at ostium Side branch pre-wired, no need to re-access through stent Final Petal size determined by post dilatation balloon

Stent Advantages Special stent feature to cover ostium of side branch (~2mm) Reduces / eliminates side branch gap May reduce frequency of 2nd stent Placing 2nd stent, when necessary, is technically more straight forward

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Chronic Total Occlusion (CTO)

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

History of Interventional Cardiology

1977

1984

1988 1989 1997 1999

2000 2002 2003 2004 2005

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

2006

Why Degradable Stents? Degradable Stents

No late adverse events
Late thrombosis Hypersensitivity reactions
(chronic inflammation)

Stent fractures

Does not restrict arterial remodeling Permits non-invasive imaging of artery Permits bypass surgery in future
Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Bioabsorbable Stent Design

.

Topcoat: Polymer B Drug Layer: Polymer B + Sirolimus Undercoat: Polymer B Core: Polymer A

Coating Layers

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Multi-Layer, Combination Drug Delivery

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Biodegradable Stents
Could also be the ideal vehicle for several other applications: non-obstructive vulnerable plaque, gene transfer for infract repair and angiogenesis..

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Biodegradable Stents: They Do Their Job and Disappear

- Ron Waksman

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Future Opportunities in Interventional Cardiology

Peripheral Vascularization -Claudication -Limb Salvage -Angiogenesis Structural Heart/ Stroke Prevention -PFO/ASD Closure -Left Atrial Appendage closure - Atrial Fib. Ablation Cerebral Revascularization -Carotid Stenting -Embolic Protection Devices -Acute Stroke Intervention Congestive Heart Failure -Resynchronization Therapy -Impulse Modulation -Implantable Pressure Regulators

Maurice Buchbinder, MD Foundation for Cardiovascular Medicine