login
  Password reminder
Vascular News
Contact the editor Visit Vascular News Twitter feed Visit Vascular News Facebook page
 

CONNECT II clinical trial completes enrolment


Wednesday, 13 Jun 2012 09:43
Ocelot
Ocelot

Avinger has announced that it has successfully completed enrolment in its CONNECT II global clinical trial. A study focused on treatment of peripheral artery disease. CONNECT II is a prospective, multicentre, non-randomised global clinical study that evaluated 100 peripheral artery disease patients with femoropopliteal chronic total occlusion lesions at 15 hospital and clinic sites, including two in the European Union.


As part of the trial, an independent group of physicians are reviewing the angiographic results to determine Ocelot’s safety and efficacy. According to Avinger (manufacturer of this device), it is the first-ever interventional chronic total occlusion (CTO) crossing catheter to use real-time intravascular imaging technology called optical coherence tomography, or OCT. It allows physicians to cross, see and navigate inside totally blocked arteries in the legs of patients suffering from peripheral artery disease.

“We are pleased to reach this significant milestone ahead of schedule and already see promising preliminary data collected,” said John B Simpson, CEO and founder, Avinger. “We appreciate the patient participation and dedicated efforts of our employees, physician investigators and their research staff. Together, we are now one step closer to bringing the Ocelot technology to patients who need it most.”


The company will present CONNECT II aggregate results at the VIVA conference (Las Vegas, USA, 9–12 October 2012), file a 510K with the FDA later this summer, and expects to receive 510K clearance in late 2012. In order to ensure Ocelot is available for use at US CONNECT II sites during the 510K review period, Avinger has also requested FDA approval of an additional 125 patients to be enrolled and treated in a continued access cohort.


“I believe the results from this trial will have a major impact on how physicians treat patients with severe peripheral artery disease. We are pleased that a request for continued access has been submitted. It means the Heart Hospital may be able to continue treating patients with Ocelot in order to quickly improve their mobility and return to a healthier quality of life,” said Matthew Selmon, Heart Hospital Austin, Texas and co-principal investigator for the trial.


“This is the first-ever interventional device that allows us to drill through the totally blocked arteries in the legs while using an integrated camera to see it from the inside,” said Arne Schwindt, St Franziskus Hospital, Muenster, Germany and co-principal investigator in the trial. “This is a major advance for patients suffering from peripheral artery disease, and holds the potential to postpone or entirely avoid surgical bypasses and amputations.”


Ocelot received CE mark in 2011.




Add New Comment

Most popular


Incraft low-profile endograft launched in Europe and Canada
Wednesday, 10 Sep 2014
Cordis announced on 10 September the launch of its Incraft AAA Stent Graft System, an ultra-low profile device for use during endovascular aneurysm repair (EVAR) for patients suffering from ... Incraft low-profile endograft launched in Europe and Canada

First patient enrolled in US study of Novate’s Sentry IVC filter
Monday, 22 Sep 2014
Novate Medical has announced that Souheil Saddekni, professor of Vascular and Interventional Radiology at the University of Alabama, Birmingham, USA, has enrolled the first patient in the SENTRY IDE ... First patient enrolled in US study of Novate’s Sentry IVC filter

First drug-eluting balloon approved in USA
Friday, 10 Oct 2014
The FDA has approved the Lutonix drug-eluting balloon for the management of peripheral artery disease. This is the first time that the agency has approved such a device for this indication in the USA. First drug-eluting balloon approved in USA

Features


Not all drug-eluting balloons are equal
Wednesday, 15 Oct 2014
Thomas Zeller, Bad Krozingen, Germany, analyses the results of two recent randomised controlled trials comparing drug-eluting balloons to angioplasty alone in femoropopliteal lesions. Not all drug-eluting balloons are equal

Renal stenting may benefit patients excluded from randomised trials, says expert consensus
Wednesday, 15 Oct 2014
Sahil A Parikh, Case Western Reserve University School of Medicine, Cleveland, USA, speaks to Vascular News about the Society for Cardiovascular Angiography and Interventions expert consensus on ... Renal stenting may benefit patients excluded from randomised trials, says expert consensus

Profiles


Martin Björck
Wednesday, 01 Oct 2014
Martin Björck, Uppsala University Hospital, Sweden, holds the only professor-chair of vascular ... Martin Björck

Cliff Shearman
Thursday, 03 Jul 2014
A former president of the Vascular Society of Great Britain and Ireland, Cliff Shearman was ... Cliff Shearman

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions