Medtronic obtains CE Mark for vascular stent
| January 25, 2013 | Cardiovascular Business | Vascular & Endovascular

Medtronic has received CE Mark and initiated an international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically, the superficial femoral arteries (SFA) and proximal popliteal arteries.

The Complete SE stent has been approved by the FDA only for use in the iliac arteries. Its use in lower-extremity arteries in the U.S. is under review by the FDA, according to Minneapolis-based Medtronic. Previously CE Marked only for use in the iliac arteries, the Complete SE stent can now be used internationally in the lower extremities as well.

The new indication was obtained after clinical data from the Complete SE SFA study, an independently adjudicated single-arm, multicenter trial that enrolled 196 patients at 28 sites in the U.S. and Europe.

Related Content

Boston Scientific recalls premixed embolic agent after two deaths
Anemia may help explain why women are more likely to die during heart bypass surgery
FDA grants anticoagulant its orphan drug designation for treating patients with implanted devices
FDA announces new recall of neurovascular catheters built by Johnson & Johnson subsidiary
GE Healthcare launching new AI software for handheld ultrasound system
New study provides ‘substantial evidence’ paclitaxel-coated devices are safe when treating lower-limb PAD

Around the web

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Radiology Business
Philips launches new AI-enabled CT scanner aimed at cardiology at ECR 2024

Philips introduced a new CT system at ECR aimed at the rapidly growing cardiac CT market, incorporating numerous AI features to optimize workflow and image quality.

Design by Adaptive Theme
Trimed Popup
Trimed Popup