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

FDA clears first ever bi-directionally retrievable vena cava filter from Crux Biomedical


Thursday, 19 Jul 2012 11:17
Tom Fogarty
Tom Fogarty


The US Food and Drug Administration (FDA) has cleared Crux Biomedical’s inferior vena cava filter with bi-directional retrieval for the prevention of pulmonary embolism. This feature allows retrieval of the device from the femoral or jugular veins, a key consideration when access to one or the other vein is limited.


“Crux designed a device that is both more versatile and simple to use,” said Tom Fogarty, cardiovascular surgeon and founder of Crux Biomedical. “Bi-directional deployment and retrieval are extremely helpful in situations where access to either the femoral or jugular vein is not possible. The Crux vena cava filter with its innovative design and materials represents a paradigm shift in prevention of pulmonary embolisms in patients at risk.”

A recently completed pivotal trial consisting of 125 patients at high risk for pulmonary embolisms, called the RETRIEVEclinical study, was performed at 22 sites in the USA, Australia, New Zealand and Belgium. The study results were presented at the 2012 Society for Interventional Radiology (SIR) meeting.


In the study, the technical success rate of filter deployment was 98%; filter retrieval success was also 98%. The average retrieval time was 7 minutes. By the 6-month follow up of the study, no embolizations, migrations or fractures were observed.


“The Crux device demonstrated excellent deployment, retrieval and safety profile,” stated Robert R Mendes, principal investigator of the study; associate professor of Surgery, University of North Carolina; and Chief of Vascular Surgery, Rex UNC Healthcare. “The clinical study evaluation has demonstrated the Crux vena cava filter can be used safely for the prevention of recurrent pulmonary embolisms.”


“The Crux vena cava filter system is the first major design innovation in vena cava filters in some 40 years,” said Mel Schatz, CEO, Crux Biomedical. “We have been pleased with both the clinical outcomes in our pivotal clinical trial and the enthusiasm expressed by physicians using the Crux vena cava filter.” The device’s novel helical shape was designed to self-center and to conform more closely to the shape of the vena cava, as well as to reduce bends and stress that can compromise filter integrity.




Add New Comment

Related Items


Most popular


Biolas introduces VariClose in Europe
Thursday, 16 Jul 2015
After the European launch in April 2015, Biolas has introduced the VariClose Vein Sealing Systems in the European market for the treatment of varicose veins. Biolas introduces VariClose in Europe

Cyanoacrylate embolisation agent non-inferior to radiofrequency ablation for incompetent great saphenous veins treatment
Friday, 03 Jul 2015
Twelve-month results from the VeClose trial have demonstrated cyanoacrylate adhesive (CAE) is non-inferior to radiofrequency ablation (RFA) for the treatment of incompetent great saphenous veins. Cyanoacrylate embolisation agent non-inferior to radiofrequency ablation for incompetent great saphenous veins treatment

Companies announce new round of renal denervation randomised trials
Monday, 08 Jun 2015
Medtronic has announced the initiation of the SPYRAL HTN clinical trial programme studying renal denervation in uncontrolled hypertension, and Boston Scientific has announced the initiation of the RED... Companies announce new round of renal denervation randomised trials

Features


Choosing horses for courses: Using liquid agents to embolize endoleaks
Monday, 27 Jul 2015
Robert Morgan, vascular interventional radiologist, St Georges Hospital, London, UK, tells Interventional News why he uses liquid embolic agents, such as ethylene vinyl oxide copolymer (EVOH-based) ... Choosing horses for courses: Using liquid agents to embolize endoleaks

Aneurysm Coiling Efficiency (ACE) registry shows positive results for Ruby coil peripheral vasculature
Wednesday, 10 Jun 2015
The Aneurysm Coiling Efficiency registry offers an opportunity to study the demographics and long-term outcomes of a cohort of patients with embolization of the peripheral vasculature using Ruby ... Aneurysm Coiling Efficiency (ACE) registry shows positive results for Ruby coil peripheral vasculature

Profiles


Lindsay Machan
Thursday, 28 May 2015
“Focussing on maximising rewards has sidelined more ideas than it has helped individual inventors. S... Lindsay Machan

Gao-Jun Teng
Thursday, 11 Dec 2014
In the future, will interventional radiology be a subspecialty of radiology, or surgery? asks Gao-J... Gao-Jun Teng

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