Abdominal Aortic Stent Graft System_Percutek Therapeutics

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Abdominal Aortic Stent Graft System

Overview

Features and Benefits

Specification

Clinical Evidence

Indication

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.

Indication

Abdominal Aortic Stent Graft System is indicated for endovascular treatment of patients with abdominal aortic aneurysms having any of the following condition:

Appropriate iliac / femoral approach

Proximal aneurysmal neck of 15 ~ 32mm in diameter

Iliac artery of 8 ~ 20mm in diameter

Having morphology suitable for endovascular repair

Length of proximal landing zone ≥10mm

Suprarenal angulation ≤60degree and infrarenal angulation≤75 degree

Landing length of distal end≥10mm

Present with any of the following conditions

Aneurysm size> 4.5cm

Aneurysm size 4 ~ 4.5cm, and growth of 0.5cm over 6 months

The maximum diameter of the aortic aneurysm is at least 1.5-fold larger than its normal diameter

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