Thoracic Stent Graft System_Percutek Therapeutics

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Thoracic Stent Graft System

Overview

Features and Benefits

Specification

Clinical Evidence

Indication

Overview

Percutek Thoracic Stent Graft System offers durable seal 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, great graft conformability. Low type I endoleak rate and great long-term patency

Dual short strutted proximal stents (5mm and 7.5mm) allow durable seal and excellent circumferential conformability

Nitinol alloy provides balance between strong radial force with excellent conformability

Various heighted stents (5mm/7.5mm/12mm/15mm) on the graft assures extreme flexibility and conformability

Increased height of distal stent to release stress and enhance seal and conformability

Smooth delivery, precise positioning and placement, well controlled deployment

Kink-resistant and low-profile delivery system (18Fr for 28mm and below stent grafts) with coverage hydrophilic coating offer smooth delivery

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

Designed for aneurysms and dissections

Great versatility with a huge size matrix (240mm long and 10mm taper grafts are available)

Dual short struts of the proximal stents provide great flexibility and excellent conformability, allowing shortest proximal landing zone (10mm) requirement

Specification

Configuration- Straight stent graft without proximal bare stent

Proximal graft diameter	Distal graft diameter	Total covered length	OD of delivery system	Taper
22mm/24mm/26mm/28mm	22mm/24mm/26mm/28mm	70mm/150mm/180mm/210mm/240mm	18Fr	0mm
30mm/32mm/34mm/36mm	30mm/32mm/34mm/36mm	70mm/150mm/180mm/210mm/240mm	20Fr	0mm
38mm/40mm	38mm/40mm	70mm/150mm/180mm/210mm/240mm	22Fr	0mm
42mm/44mm/46mm	42mm/44mm/46mm	70mm/150mm/180mm/210mm/240mm	24Fr	0mm

Configuration- Tapered stent graft without proximal bare stent

Proximal graft diameter	Distal graft diameter	Total covered length	OD of delivery system	Taper
26mm	22mm	150mm/180mm/210mm/240mm	18Fr	4mm
28mm	22mm/24mm	150mm/180mm/210mm/240mm	18Fr	4mm/6mm
30mm	22mm/24mm/26mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm
32mm	22mm/24mm/26mm/28mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm/10mm
34mm	24mm/24mm/26mm/30mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm/10mm
36mm	26mm/28mm/30mm/32mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm/10mm
38mm	28mm/30mm/32mm/34mm	150mm/180mm/210mm/240mm	22Fr	4mm/6mm/8mm/10mm
40mm	30mm/32mm/34mm/36mm	150mm/180mm/210mm/240mm	22Fr	4mm/6mm/8mm/10mm
42mm	32mm/34mm/36mm/38mm	150mm/180mm/210mm/240mm	24Fr	4mm/6mm/8mm/10mm
44mm	34mm/36mm/38mm/40mm	150mm/180mm/210mm/240mm	24Fr	4mm/6mm/8mm/10mm
46mm	36mm/28mm/30mm/42mm	150mm/180mm/210mm/240mm	24Fr	4mm/6mm/8mm/10mm

Configuration- Straight stent graft with proximal bare stent

Proximal graft diameter	Distal graft diameter	Total covered length	OD of delivery system	Taper
22mm/24mm/26mm/28mm	22mm/24mm/26mm/28mm	80mm/150mm/180mm/210mm/240mm	18Fr	0mm
30mm/32mm/34mm/36mm	30mm/32mm/34mm/36mm	80mm/150mm/180mm/210mm/240mm	20Fr	0mm
38mm/40mm	38mm/40mm	80mm/150mm/180mm/210mm/240mm	22Fr	0mm
42mm/44mm/46mm	42mm/44mm/46mm	80mm/150mm/180mm/210mm/240mm	24Fr	0mm

Configuration- Tapered stent graft with proximal bare stent

Proximal graft diameter	Distal graft diameter	Total covered length	OD of delivery system	Taper
26mm	22mm	150mm/180mm/210mm/240mm	18Fr	4mm
28mm	22mm/24mm	150mm/180mm/210mm/240mm	18Fr	4mm/6mm
30mm	22mm/24mm/26mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm
32mm	22mm/24mm/26mm/28mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm/10mm
34mm	24mm/24mm/26mm/30mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm/10mm
36mm	26mm/28mm/30mm/32mm	150mm/180mm/210mm/240mm	20Fr	4mm/6mm/8mm/10mm
38mm	28mm/30mm/32mm/34mm	150mm/180mm/210mm/240mm	22Fr	4mm/6mm/8mm/10mm
40mm	30mm/32mm/34mm/36mm	150mm/180mm/210mm/240mm	22Fr	4mm/6mm/8mm/10mm
42mm	32mm/34mm/36mm/38mm	150mm/180mm/210mm/240mm	24Fr	4mm/6mm/8mm/10mm
44mm	34mm/36mm/38mm/40mm	150mm/180mm/210mm/240mm	24Fr	4mm/6mm/8mm/10mm
46mm	36mm/28mm/30mm/42mm	150mm/180mm/210mm/240mm	24Fr	4mm/6mm/8mm/10mm

Clinical Evidence

The clinical trial of Percutek's Thoracic Stent Graft System is a multicenter, concurrent parallel controlled non-inferiority trial.
A total of 166 patients in 10 sites were enrolled, including 81 in the experimental group and 85 in the control group.
The primary effectiveness endpoint was the percentage of patients who were successfully treated for thoracic aortic dissection. The success rate was 98.7% in the experimental group90.0% in the control group.

Table 1 Results of effectiveness evaluation:

	FAS set		PPS set
Success rate	Experimental group	Control group	Experimental group	Control group
Success rate	93.8%	85.7%	98.7%	90.0%

The primary safety endpoint was the major adverse events during the perioperative period (0-30 days) of the Thoracic Stent Graft System. There was no statistical difference between experimental group and control group.

Table 2 Results of safety evaluation:

Major Adverse Events (MAE) within 30 days	Experimental group	Control group
All-cause death	1.3%	0%
Gastrointestinal hemorrhage	0%	0%
Myocardial infarction	0%	0%
Paraplegia	0%	0%
Intraoperative blood loss ≥1000cc	0%	0%
Renal failure	0%	0%
Respiratory failure	0%	1.2%
Stroke	0%	0%
Implant infection	0%	0%
Total	1.3%	1.2%

The results of Percutek's Thoracic Stent Graft System met the endpoints. All clinical data show that Percutek's Thoracic Stent Graft System is a safe and effective medical device for the treatment of thoracic aortic disease.

Indication

Percutek Thoracic Stent Graft System is indicated for endovascular treatment of patients with diseases of the descending thoracic aorta including but not limited to aneurysms and dissections, having the following condition.

Appropriate iliac / femoral approach

Diseases of the descending thoracic aorta, and neck diameter ranging 20 ~ 44mm

The length of proximal landing zone ≥10mm, without significant calcification and / or significant thrombosis

Having anatomic morphology suitable for endovascular repair

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