FDA Panel Backs Aortic Aneurysm Repair Device | IUK Med Online
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FDA Panel Backs Aortic Aneurysm Repair Device

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FDA Panel Backs Aortic Aneurysm Repair Device

Incraft stent graft system safe and effective, committee members say

MedpageToday

  • by Reporter, MedPage Today/CRTonline.org

An FDA advisory committee voted in favor of premarket approval for the Incraft abdominal aortic aneurysm (AAA) Stent Graft System for endovascular repairs, manufacturer Cardinal Health/Cordis announced.

The FDA Circulatory System Devices Panel voted 11-4 on Tuesday both that the endovascular aneurysm repair (EVAR) device has benefits in the treatment of infrarenal AAAs and that it is safe for use in the proposed population.

The vote was even more favorable (14-0, with one abstention) for effectiveness in patients who meet the criteria specified in the proposed indications.

Incraft received Europe’s CE mark in 2014, according to a statement.

The basis of much of the panel discussion was INSPIRATION, a 190-person, single-arm study in which the EVAR system met its primary safety and effectiveness endpoints by demonstrating a 3.2% rate of major adverse events at 30 days and an 87.9% rate of successful aneurysm treatment at 1 year.

Over 4 years of follow-up, one-fifth of patients died but without any aneurysm ruptures reported to date in the study.

One issue of note was that 19 out of 190 study subjects showed at least one stent strut fracture in the bare transrenal stent that helps the endovascular graft fixate to the abdominal aorta. The sponsor reported no clinical events that can be attributed to these stent strut fractures.

Even so, 18 out of those 19 patients with transrenal stent fractures were first identified by the core lab and not investigational sites, meaning that device recipients could have fractures that are missed by their following physicians, according to a briefing document prepared ahead of the meeting.

The FDA is not obliged to follow its advisory panels’ recommendations, but it usually does.

2018-06-13T15:30:00-0400
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Medpage Today

FDA Panel Backs Aortic Aneurysm Repair Device

Incraft stent graft system safe and effective, committee members say

MedpageToday

  • by Reporter, MedPage Today/CRTonline.org

An FDA advisory committee voted in favor of premarket approval for the Incraft abdominal aortic aneurysm (AAA) Stent Graft System for endovascular repairs, manufacturer Cardinal Health/Cordis announced.

The FDA Circulatory System Devices Panel voted 11-4 on Tuesday both that the endovascular aneurysm repair (EVAR) device has benefits in the treatment of infrarenal AAAs and that it is safe for use in the proposed population.

The vote was even more favorable (14-0, with one abstention) for effectiveness in patients who meet the criteria specified in the proposed indications.

Incraft received Europe's CE mark in 2014, according to a statement.

The basis of much of the panel discussion was INSPIRATION, a 190-person, single-arm study in which the EVAR system met its primary safety and effectiveness endpoints by demonstrating a 3.2% rate of major adverse events at 30 days and an 87.9% rate of successful aneurysm treatment at 1 year.

Over 4 years of follow-up, one-fifth of patients died but without any aneurysm ruptures reported to date in the study.

One issue of note was that 19 out of 190 study subjects showed at least one stent strut fracture in the bare transrenal stent that helps the endovascular graft fixate to the abdominal aorta. The sponsor reported no clinical events that can be attributed to these stent strut fractures.

Even so, 18 out of those 19 patients with transrenal stent fractures were first identified by the core lab and not investigational sites, meaning that device recipients could have fractures that are missed by their following physicians, according to a briefing document prepared ahead of the meeting.

The FDA is not obliged to follow its advisory panels' recommendations, but it usually does.

2018-06-13T15:30:00-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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Dr Irfanullah Khan Born: 15th July,1994 in Khagram,Dir Upper KPK Pakistan. Others names:Doctor Irfo,Peshoo Education:Pharm-D Scholar Graduated from Abasyn University Peshawar. Occupation:Clinical Pharmacist,Doctor,Entrepreneur. Home Town:Dir Upper Height: 6 feet. Website:Iukmedonline.com

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