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


OVER analysis: Endoleak does not predict reduced long-term survival but negatively impacts sac regression
Wednesday, 18 Jun 2014
An analysis of the OVER trial presented at the Society for Vascular Surgery Vascular Annual Meeting (SVS, 5–7 June, Boston, USA) shows that the development of endoleaks were common in patients ... OVER analysis: Endoleak does not predict reduced long-term survival but negatively impacts sac regression

Medtronic to acquire Covidien for US$42.9 billion in cash and stock
Monday, 16 Jun 2014
The acquistion creates a medical technology and services company with a comprehensive product portfolio and broad global reach. Medtronic to acquire Covidien for US$42.9 billion in cash and stock

FDA advisory panel unanimously recommends approval for Lutonix DCB
Friday, 13 Jun 2014
Lutonix DCB is one step closer to becoming the first US FDA-approved drug-coated balloon for the treatment of patients with femoropopliteal occlusive disease. FDA advisory panel unanimously recommends approval for Lutonix DCB

Features


The 11th Scientific Meeting of the Chinese Society of Interventional Radiology successfully held in Changsha
Tuesday, 08 Jul 2014
The 11th Scientific Meeting of the Chinese Society of Interventional Radiology (2014 CSIR) was held from 11–15 June 2014 in Changsha, Hunan Province, China. The Chinese Society of Interventional R... The 11th Scientific Meeting of the Chinese Society of Interventional Radiology successfully held in Changsha

Pressure-directed embolotherapy using antireflux devices to perform liver directed regional therapy
Tuesday, 08 Jul 2014
Unintended non-target delivery of embolic agents into any of the various hepaticoentric arteries that course from an intrahepatic artery to implant into an extra hepatic organ such as the stomach or ... Pressure-directed embolotherapy using antireflux devices to perform liver directed regional therapy

Profiles


Bien Soo Tan
Friday, 16 May 2014
Bien Soo Tan, senior consultant, Department of Diagnostic Radiology, Singapore General Hospital, S... Bien Soo Tan

James B Spies
Friday, 16 May 2014
The evolution of embolization over the past decade has been remarkable and it has fundamentally ... James B Spies

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