1. Access Closure Devices: A Changing Paradigm
Mark A. Turco, MD, FACC, FSCAI
Director, Center for Cardiac and Vascular Research
Washington Adventist Hospital
Takoma Park, Maryland
Assistant Professor of Medicine
Uniformed Services University of the Health Sciences
Bethesda, Maryland
tle of Presentation by First Name Last Name, Degree

2. Mark A. Turco, MD DISCLOSURES Honoraria Grants/Contracted Research
Boston Scientific, Medtronic CardioVascular, Inc., Abbott Vascular
Grants/Contracted Research

3. Limitations of manual compression
Delayed ambulation
Patient dissatisfaction/discomfort
Time and personnel intensive
Vascular complications in anticoagulated pts
still occur after successful hemostasis obtained
by manual compression

4. Access Site Treated Post-Procedure4

5. Current FDA approved VCDs
Vendor Product Closure Method
Abbott Vascular Perclose AT Suture
Perclose Proglide Suture
Perclose ProStar XL Suture
Starclose SE Nitinol clip
Access Closure Mynx Extravascular PEG sealant
Cardiva Medical Boomerang Arteriotomy tampanode
St Jude Medical Angio-Seal Evolution Mechanical seal
Angio-Seal VIP
Angio-Seal STS Plus
Sutura Super Stitch Suture and knot
Vascular Solutions Duett Pro Thombin/collagen pro-coagulant

6. Closure Technology ACTIVE VS PASSIVE
ACTIVE: Mechanical approximators are active ie. Angio-Seal, Perclose, Starclose
PASSIVE: Cardiva Catalyst, Mynx
INTRALUMINAL vs EXTRALUMINAL
ie. Mynx and StarClose are Extraluminal

7. Categories of Vascular Closure Devices
Anchored plugs
Suture closure
Clip/staple closure
Unanchored plugs
“No footprint” devices
Topical patches
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8. Closure Begins with Access
Decision to use
made before access
Closure technique
in place during the case itself
rather than deployed in entirety after
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9. New Generation Extravascular Devices Address These Issues
1st Generation Limitations
Thrombogenic collagen plug or liquid procoagulant
New Generation Devices
Non-thrombogenic material
Inconsistent deployment
Fail-safe indicators and easier deployment
Non-mechanical seal
Acts mechanically - sealant rapidly expands and fills tissue tract
Low Rates of Major Complications

10. Late Clinical Presentation of Femoral Artery Occlusion After Deployment of the Angio-Seal Closure Device
                                  
VOLUME: 14 PUBLICATION DATE: Nov
Issue Number: 11 (Nov 2002)
Vascular Disease Management

11. AngioSeal Closure Device Related Dissection: Anchor-Related Trauma in a Normal Vessel
VOLUME: 2 PUBLICATION DATE: Nov
Issue Number: 6
Vascaular Disease Management
Shahrzad Shareghi, MD and David M. Shavelle, MD

12. Benefits of Extravascular Closure
No risk of flow obstruction from intraluminal components
Lower risk of catastrophic complications – no intravascular components that can detach and lodge distally.
Clinical versatility – fewer anatomical constraints that typically limit intra-arterial VCD use
Lack of inflammation and scar tissue from intra-arterial components

13. ExtraVascular Closure: Benefits
EXTRAVASCULAR, LEAVES NOTHING BEHIND
Provides a durable hemostasis?
Dissolves within 30 days?
PATIENT-FRIENDLY
CLINICALLY VERSATILE
Designed to minimize pain
Avoids tugging and cinching of artery
No sutures or permanent metal implants
Treats wide range of patients and clinical scenarios
Preserves vessel integrity
No intravascular components

14. Plug Position in Anatomy
Femoral Sheath/ Fascia
Upper picture:
Note how plug is secured beneath the femoral sheath/fascia after device deployment
Plug is positioned above arteriotomy at the outer margin of the vessel wall
Lower picture
Arteriotomy
Plug
Data on File, Synecor Study DVT07-004, 3/5/2007 14

15. New Generation Extravascular Devices
Conformable porous sealant provides immediate hemostasis independent of clot formation
As blood collects inside the sealant it clots providing a platform for natural vessel healing
12 psi to dislodge sealant – equivalent to a mean arterial pressure of > 600mmHg
Arteriotomy coverage
~double the diameter of the largest 7F sheath
Microscopy Image of Mynx Sealant
Dry sealant diameter 1.8 mm
Hydrated sealant diameter ~ 6.3 mm

16. New Technology
MYNX
FISH
ARSTASIS
BOOMERANG

17. The Mynx® Vascular Closure Device Passive and Extraluminal17

18. Balloon for Temporary Hemostasis
Mynx Vascular Closure Family: 6F/7F Mynx and M5 Mynx (5F)
Handle and Shuttle
Sealant is freeze-dried and integrated into delivery catheter
6 mm semi-compliant balloon
Delivered through existing 5F, 6F, 7F sheath
Diagnostic and interventional indication
Sealant
The Mynx sealant:
95% water and 5% PEG
Extravascular placement; Leaves nothing behind
Dissolves within 30 days
Balloon for Temporary Hemostasis 18

19. The Mynx Family
The Mynx is currently available in two sizes, eliminating the need for a sheath exchange.*
6F/7F Mynx
Mynx M5
for 6F and 7F procedural sheaths
for 5F procedural sheaths
* Mynx is compatible with a 5F, 6F or 7F procedural sheath with an overall length less than or equal to 15.7cm
MKT2803.B
MKT2803.B

20. Collagen vs. PEG Collagen PEG Thrombogenic Non-thrombogenic
Animal (bovine or porcine)
Synthetic
Enzymatic degradation
Hydrolytic degradation
Resorbs within 90 days
Resorbs within 30 days
Fibrous consistency
Tissue-like consistency
MKT2803.B
MKT2803.B 20

21. Procedure Overview
Insert Mynx into existing 5F, 6F or 7F procedural sheath* and inflate small semi-compliant balloon to create temporary hemostasis. 1
Deliver and unsleeve sealant, exposing it to blood and subcutaneous fluids, producing a durable hemostasis. 2
Deflate balloon and remove device. Sealant is located on surface of arteriotomy, providing immediate hemostasis.
* Mynx is compatible with a 5F, 6F or 7F procedural sheath with an overall length less than or equal to 15.7cm 3 21

22. Microscopy of Sealant
Microscopy image of dry, compressed sealant showing macroporous structure, which allows for rapid fluid uptake and expansion 22

23. Post Market Studies to Date (2,071 patients studied)
Institution
Study Design and Outcomes
Key Take-Aways
Scheinert, et al.
5 European Centers
(Original Mynx Study)
190 pts (Dx and Ix)
92.3% Device Success
0.5% Major Comps
3.7% Minor Comps
Safety and Efficacy
Low comp rate
Rapid TTH regardless of ACT
Ease of Use
Brown, C.
Piedmont Hospital
Atlanta, GA
761 pts (Dx and Ix) 98.7% Device Success 0.67% Major Comps
0.53% Minor Comps
Extravascular
Versatile (obese, bifurcation stick)
No sheath exchange
Increased patient comfort
Kabour, A.
St. Vincent Mercy
Toledo, OH
454 (Dx and Ix) 95.4% Device Success
0% Major Comps 0.88% Minor Comps
Similar outcomes in dx/int, BMI, diabetes, gender
Extravascular- Clinical versatility
Short learning curve
Wolford, D.
Baptist Memorial
Memphis, TN
666 patients (Dx and Ix) 98.9% Device Success
0.3% Major Comps
0.45% Minor Comps
High success, low comps
Patient comfort
Restick ability

24. Two Very Different Concepts
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Arstasis
FISH 24

25. FISH

26. SIS – Small Intestinal Submucosa
The SIS matrix provides an infrastructure for cell growth, as shown below:
SIS is a 3 dimensional scaffold material. After implant, adjacent cells attach to the SIS. Capillary growth follows to supply nutrients to the inner cells promoting 3 dimensional repair, and new tissue completely resembles host tissue.

27. How FISH Works SIS Closure Patch Release Wire Cap Suture Tether
Positioning Cuff
Release Wire
Side Port

28. Sheath Positioned in Vessel

29. Position

30. Compression

31. Healing

33. Step 1 – Micropuncture Access

34. Device Through Micropuncture Hole

35. Heel Deployed/Device Pulled Back

36. Sheath Access Path Created
Needle deployed at shallow angle across vessel wall
Wire then advanced through needle

37. Wire Left in Place
Needle retracted
Heel is then folded

38. Device Removed

39. Sheath Then Placed Over Wire
Primary Hole
Compressed
By Sheath

40. Boomerang

41. Bifurcation Stick, High Stick, Calcification
Severe PVD
Bifurcation Stick
5000 Units Heparin & Integrilin (ACT 208)

42. Conclusion
With new generations of VCD extravascular devices are beginning to demonstrate safety and efficacy similar or better to other devices leaving nothing behind.
Safety advantages are seen with extravascular devices.
Expanding closure to PAD patietns with calcification, Bifurcation, Large vessel holes, and high sticks are what is needed.