1. Transfemoral Access Devices & Tips for Closure Devices
James P. Zidar, M.D., F.A.C.C., F.S.C.A.I
Clinical Professor of Medicine, UNC Health Systems
UNC Health System Physician-in-Chief, Heart & Vascular
Corporate Chief of Cardiology, Rex Healthcare
Raleigh, North Carolina

2. Disclosures
In the past year, I have been on a scientific advisory board, worked as a consultant for, or conducted clinical research for:
Abbott Vascular, BSC, Medtronic, and Siemens

3. Closure Devices 3

4. Compaction & Compressive Sealing Force
Angio-Seal™ Evolution™
Compaction & Compressive Sealing Force
What is compressive sealing force?
Force between the collagen and the anchor after completion of Angio-Seal™ deployment
Critical part of achieving hemostasis
Consistent Collagen Compaction Forces

5. Why Big Holes?
26 Fr
23 Fr
18 Fr
14 Fr
12 Fr
Introduction of lower profile Endovascular thoracic and abdominal devices have expanded the market to a potential of 5 million people
Closure devices have facilitated the adoption of transcatheter aortic valves, AAA endografts and LV support devices for high risk PCI

6. Most physicians currently use Abbott’s closure devices for large access closure1,2
Suture-based Prostar XL and Perclose ProGlide are used to “pre-close” EVAR access sites1,2
Perclose is the preferred device due to its easy of use1

7. Femoral Anatomy Landmarks
Anterior superior
iliac spine
Inguinal
skin crease
ligament
Femoral
head
Common
femoral
artery
Superficial
Profunda X
CFA
PFA
SFA

8. Our Standard Approach Learn from the CTA
Anterior superior
iliac spine
Inguinal
skin crease
ligament
Femoral
head
Common
femoral
artery
Superficial
Profunda
Learn from the CTA
Puncture the contralateral femoral artery and perform an arteriogram with Rim or pigtail catheter
make a cross with 2 small needles with the maximum pulse vertically and the groin grease horizontally
If CKD, advance pigtail to mid femoral head and give 2 cc of contrast
If height is perfect, puncture vessel in the center of the circle
Place a short 6Fr sheath over a standard J wire.
Some groups use U/S guidance

9. Abbott Vascular – Perclose® Device How Does it Work?
Locate anterior wall of artery
Needles deploy suture on either side of the arteriotomy
Deploy 2 ProGlides at 10 and 2 positions and secure with hemostats
Exchange for stiff wire with the 1st dilator
Perform TAVR or EVAR
Tissue is pulled closed with sutures at end of procedure with hand pressure upstream
Options with higher risk patient
Occlude aorta with a soft Cook Coda balloon in distal aorta
Advance a .018” Steelecore wire over a Rim catheter into distal SFA from contralateral groin
Pull TAVR sheath back to mid EIA and occlude CIA with an 8 x40 mm balloon at low pressure while pulling the TAVR sheath and tightening sutures.

10. Most physicians use suture based closure systems to “pre-close” the large arteriotomies
Step 1: The device is deployed over a wire prior to any interventions1
Step 2: The deployed device is removed leaving the sutures in place around the arteriotomy1
Step 3: Interventional devices are tracked through the vasculature with the sutures in place1
Step 4: Following interventions, the vessel is closed with pre-deployed sutures1 S

11. Complications of Pre-close technique
Inadequate closure
5-20% failure rate
Suture breakage
Device misfire
Embolism
Infections
Hematoma

12. Pre-close technique: 2 ProGlide devices are crossed at 40o and “pre-closed”
Each Perclose (6Fr) device costs ~$390, which equals to ~$780/case
Prostar XL 10 approved for 8.5 to 10Fr closure; Each costs ~$900

13. The InSeal VCD (Vascular Closure Device)
Acute
After biodegradation
Clinic Experience
80+ patients were treated with the InSeal VCD
FIH study in Brazil (20 pts) followed by studies in EU & Israel
No chronic complication (most followed by ultrasound for 12M)
Tether (biodegradable)
Sealing membrane
(biodegradable)
Nitinol frame

14. InClosure Deployment – 4 Easy steps
The InClosure VCD is easy & effective. It takes just minutes to learn and master the system…
Prof. Ran Kornowski, MD, FESC, FACC
InSeal Medical Confidential

15. CLOSURE DEVICE Fully synthetic absorbable low-profile implant
No sutures, collagen or clips
Easy post-procedure deployment
CLINICAL EXPERIENCE
> 100 patients
Sapien 3, Evolut R, Lotus, Core Valve, Portico
MAE 0% (all time points)
CE Mark approved

16. Essential Medical - MANTA Closure
Proven Concept, New Application
14F & 18F versions
For 10-25F PUNCTURES
Simple and Quick Closure
Fast Hemostasis

17. MANTA Principle of Operations
Innovative positioning, control and release

18. MANTA CE MARK Approval Trial (n=50) Procedure Specifics
Procedure Sheath
Sheath OD (F) n
MANTA
BAV and VAD
12 & 14F Cook 3
14F
Evolut R
Sheathless – 14F 18 13
Direct Flow
18F Direct Flow 22 5
18F
Lotus
(23mm)
Small Lotus – 18F
Sapien 3
(23 and 26mm)
14F eSheath 23 9
(25 and 27mm)
Large Lotus – 20F 24
(29mm)
16F eSheath
24.5
Other
Various 7

19. Hemostasis time < 10 min
ENDPOINTS
N=50
All-cause Mortality
4 (8%)
Disabling Stroke
Minor Stroke
1 (2%)
Major vascular Complications
covered stent
Minor Vascular Complications
Need for Packed Cells Transfusions
9 (18%)
None device related
Hemostasis Success
47 (94%)
Hemostasis time < 10 min
Deployment time
1-2 minutes
Median Time to Hemostasis
23 seconds

20. Vascular Closure Devices Have Patient Limitations
Peripheral vascular disease
Bifurcation sticks
Small femoral vessels
Obesity/Low BMI

21. Caveats Initial Access Matters Learning Curve
Spend the extra minute to make an adequate tissue track
We still do not have the ideal device