Leipzig Registry : IDEV Technologies

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Leipzig Registry

An ongoing registry trial conducted at Park Hospital and Heart Center in Leipzig, Germany is evaluating the safety and efficacy of the SUPERA stent in the superficial femoral artery (SFA) and popliteal arteries. Interim results from this trial have been presented at major international conferences. At the 2011 Leipzig Interventional Course (LINC) data was presented for two year follow-up data in the SFA and one year follow-up in the popliteal arteries.

The chart below summarizes primary patency data for the registry.

SFA Registry: Primary Patency (Complete 2-year Data)
Follow-Up Window	Patency
6 months	93.1%
12 months	84.7%
18 months	76.1%
24 months*	76.1%

Click here for the latest LINC SFA presentation.

Popliteal Registry: Primary Patency (Complete 12-month Data)
Follow-Up Window	Patency
6 months	95.7%
12 months	87.4%
18 months	76.5%
24 months	76.5%

Click here for the latest LINC Popliteal presentation.

While it is difficult to compare outcomes from trials with variable designs, methods, and end points, the chart below summarizes key data from various SFA stent trials.

Study	Stent	Lesion Length (cm)	Patients	Fracture Rate (%)	Primary 12 Month Patency
Leipzig	SUPERA	9.0	107	0	85%
CWZ	SUPERA	24.0	182	0	74%
Saxon	Viabahn	14.2	76	0	76%
Zilver RCT	Zilver PTX	5.4	361	0.9	83%
Zilver SAS	Zilver PTX	10.0	787	1.6	83%
Vienna	Absolute	10.1	51	2	63%
Vibrant	Viabahn Arm	19.0	72	2	72%
Resilient	LifeStent	7.1	134	3.1	81%
Sirocco II	SMART (DES)	8.2	57	8	82%
Durability II	EverFlex	8.9	287	0.4	68%
FAST	Luminexx	4.5	123	12	67%
Super-SL	SMART	13.4	96	22.4	65%
Vibrant	BMS Arm	16.0	76	30.8	58%

SUPERA® is a different
class of stent.