CE Mark And First Clinical Use For Acandis® Acclino® 1.9F Neuro Stent System

In short

German Neurovascular device company Acandis GmbH & Co KG, has announced the CE mark approval of its novel Acclino® 1.9F low profile stent system, designed for use in the interventional neurovascular field as an adjunctive product in treating intracranial aneurysms with coils.

The Acclino stent is offered as a complete set for use together with the Acandis® 1.9F microcatheter and according to the company redefines the standard of success for physicians and patients.

At the same time as announcing its regulatory approval the company has also trumpeted the first clinical use of the device by Prof. Dr. René Chapot, Head of Neuroradiology Department, Alfried Krupp Hospital (Essen, Germany).

Background

With sizes compatible for vessel diameters of 2 – 4 mm, the Acclino stent is suitable for all of the cerebral main vessels and those even more distal and rather difficult to reach, where a low profile delivery system is essential.

The laser cut nitinol stent serves as a scaffold for neurovascular coils and its unique closed cell design provides conformability even in curved segments, with true vessel reconstruction at the neck of the aneurysm.

The Acclino® 1.9F Stent System is recapturable and repositionable up to 90% of its deployed length, therefore providing a safe delivery of the stent with great accuracy. Radiopaque transport wire markers for positioning and gold markers at the stent ends for visualisation of the stent additionally support accurate deployment.

Coils can be delivered by navigating the Acandis® 1.9F low profile microcatheter (inner lumen of 0.0165”) through the stent struts into the aneurysm. This obviously eliminates the need for catheter exchange. According to Acandis, the low profile concept allows also aneurysm treatment by “jailing technique”.

Clinician comments

First procedures utilising this novel low profile stent system have been conducted by Prof. Dr. René Chapot, who commented; “I appreciate how easily the new 1.9F microcatheter tracked through tortuous anatomy. This system makes it very straightforward to position the stent accurately as there is very low friction during delivery and minimal stent foreshortening. In addition the stent opening and wall apposition due to the optimal radial force is really convincing.”.

Company comments

“The Acandis® Acclino® 1.9F Stent System is clearly a next generation stent system to treat intracranial aneurysms and we will continue to bring more of this kind of engineering stroke solutions” said Kirsi Schüßler, CEO of Acandis.

Availability

The company plans to launch the product in Europe and other CE Mark countries during the 3rd quarter of 2012.
The Acandis® Acclino® 1.9F Stent System supplements Acandis’ existing NEURO CLOSED Stent System (with its 0.027” delivery system) for aneurysm treatment and the Aperio® Thrombectomy System for acute ischemic stroke.

Note: Acandis®, Acclino®, Aperio® are registered trademarks of Acandis GmbH & Co. KG

Source: Acandis GmbH & Co. KG