Cook Medical launches Zenith Low Profile (LP) and TriVascular launches the Ovation stent graft in Europe after receiving their CE marks.
Zenith Low Profile
Cook Medical launched the new Zenith LP graft at the 2010 ESVS annual meeting in Amsterdam after receiving CE mark in July.
Zenith LP is designed to have Zenith Flex AAA performance in a 16F sheath. The new graft weave is still dacron and is thinner with a more dense weave (the Zenith Flex AAA graft material alone would not fit in a 16F sheath). Nitinol is low-profile whilst maintaining high radial force.
The graft carries features from the Zenith flex graft: suprarenal bare stent fixation as well as a long main body to provide both longitudinal support and ease of contralateral limb catherterisation. The Zenith LP graft is delivered through a 16-18F (outer) hydrophilic, braided flexor sheath. It is launched as an addition to the existing Zenith Flex device and intended primarily for use in patients with poor iliac access.
Interim results from the CE mark trial saw all Zenith devices deployed successfully.
There were cases of limb occlusion associated with anatomical factors such as pre-existing stenosis and narrowing. There was no migration observed or type I, III or IV endoleaks and only one case of aneurysm growth associated with a type II endoleak. Patient enrolment and follow-up are continuing in support of global regulatory approvals.
TriVascular received CE mark approval for the Ovation Abdominal Stent Graft in September and had the first commercial case in Germany earlier this month.
The Ovation abdominal stent graft is a suprarenal stent with anchors for fixation. The fill polymer is an in-situ gelling polymer, stable, biocompatible and soluble and supplied in ready-to-mix kit with a 15 stroke mix. The autoinjector provides reliable, pressure-controlled filling with low-pressure and requires no physician attention after connection.
The 14F outer diameter system is designed to expand the patient population suitable for EVAR by addressing a wider range of diseased anatomies.
Early results seem to indicate that the pool of patients that can be offered a minimally invasive EVAR solution may be greatly expanded because of the significant reduction in profile as well as the unique sealing technology.
“The Ovation System is a novel technology that optimizes the two most important requirements for EVAR, fixation and seal,” said Michael Dake, Cardiothoracic Surgery at Stanford University School of Medicine, USA.