Percutek AAA Stent Graft

 
 
 
 
Overview
Percutek Abdominal Aortic Stent Graft System offers durable seal with active fixation, and great graft conformability. Low type I/II endoleak rate and great long-term patency are assured. The innovative design provides smooth delivery, precise positioning and placement, and well controlled deployment. Its broad coverage of challenging anatomies and wide range of indications are also remarkable.
 
Features and Benefits

Durable seal with active fixation, great graft conformability. Low type I endoleak rate, extremely low type II endoleak rate and great long-term patency
  • Optimal M-shaped proximal stents allow durable seal and excellent circumferential conformability
  • Single-suturing design offers great flexibility
  • Nitinol alloy helps balance between strong radial force with excellent conformability
  • Anchoring pins on the suprarenal stent provide active fixation without device migration
Smooth delivery, precise positioning and placement, well controlled deployment
  • Kink-resistant and low-profile delivery system (16Fr for 22mm and below stent grafts) with coverage hydrophilic coating offer smooth delivery
  • Equal-sign shaped markers provide precise positioning
  • Post-release mechanism assures well controlled deployment
  • Adjustable re-positioning even after up to 3 stents deployment
Broad coverage of challenging anatomies and wide range of indications
  • Three-piece design allows flexible and adjustable overlapping options
  • Optimal M-shaped proximal stents and single-suturing design provide great flexibility and excellent conformability, allowing shortest proximal landing zone (10mm) and largest infrarenal angulation (75º) requirements

  

Specification

Configuration- Main body

 

Proximal graft diameter

Distal graft diameter

Total covered length

OD of delivery system

20mm/22mm

12mm

110mm

16Fr

24mm

12mm

110mm

18Fr

26mm/28mm

14mm

110mm

18Fr

30mm/32mm/34mm/36mm

14mm

110mm

20Fr

 

Configuration- Limb

 

Proximal graft diameter

Distal graft diameter

Total covered length

OD of delivery system

16mm

10mm/13mm/16mm

60mm/80mm/95mm/110mm/125mm/140mm/155mm

14Fr

16mm

16mm

155mm

16Fr

16mm

20mm

60mm/80mm/95mm/110mm/125mm/140mm/155mm

16Fr

16mm

24mm

60mm/80mm/95mm/110mm/125mm/140mm/155mm

18Fr


* exception- 16Fr, instead of 14Fr, applies to PAIL1616155

 

Configuration- Iliac extension

 

Proximal graft diameter

Distal graft diameter

Total covered length

OD of delivery system

10mm

10mm

80mm

14Fr

13mm

13mm

80mm

14Fr

20mm

20mm

80mm

16Fr

24mm

24mm

80mm

18Fr

 

Configuration- PAUI

 

Proximal graft diameter

Distal graft diameter

Total covered length

OD of delivery system

18mm/20mm/22mm

14mm

110mm

16Fr

24mm/26mm/28mm

14mm

110mm

18Fr

30mm/32mm/34mm/36mm

14mm

110mm

20Fr

 

Configuration- Cuff

 

Proximal graft diameter

Distal graft diameter

Total covered length

OD of delivery system

20mm/22mm

20mm/22mm

45mm/70mm

16Fr

24mm/26mm/28mm

24mm/26mm/28mm

45mm/70mm

18Fr

30mm/32mm/34mm/36mm

30mm/32mm/34mm/36mm

45mm/70mm

20Fr

 
* All of these specifications are for straight stent graft.
 
Clinical Evidence

The clinical trial of Percutek's Abdominal Aortic Stent Graft System was an open-label, non-randomized, concurrent controlled clinical trial.
A total of 153 patients were enrolled in 11 sites, including 82 patients in the experimental group and 71 patients in the control group.
The primary effectiveness endpoint was the percentage of patients who were successfully treated for abdominal aneurysms. The success rate of was 95.8% in the experimental group and 90.6% in the control group.

 

Table 1 Success rate of abdominal aneurysm treatment (adjusted PPS set):

 

 

Experimental group (%, m/n)

Control group (%, m/n)

Success rate

96.0% (72/75)

91.0% (61/67)


 

 

The primary safety endpoint was the percentage of patients who had no major adverse events during the perioperative period. 97.5% of patients in the experimental group had no major clinical adverse events within 30 days (perioperative period), compared with 97.0% of patients in the control group.

 

Table 2 Safety evaluation:

 

 

Experimental group (%, m/n)

Control group (%, m/n)

Rate of freedom from major adverse events within 30 days

97.5% (79/81)

97.0% (65/67)

The results of Percutek's Abdominal Aortic Stent Graft System met the clinical endpoints. All clinical data show that Percuteks Abdominal Aortic Stent Graft System is a safe and effective medical device for the treatment of abdominal aortic diseas.

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