FDA Approvals: Gore Bioabsorbable Hernia Plug, NeuroFlo, Taxus Express[2], Cypher

Yael Waknine

April 22, 2005

April 22, 2005 -- The U.S. Food and Drug Administration (FDA) has approved a resorbable hernia plug for use as an alternative to permanent devices in hernia repair; a humanitarian device exemption for an aortic catheter, allowing its use for the treatment of cerebral ischemia in acute vasospasm; and a condition of use for two drug-eluting coronary stents, allowing immediate postimplantation use of magnetic resonance imaging.

Completely Resorbable Device (GORE Bioabsorbable Hernia Plug) for Hernia Repair

On April 15, the FDA approved a completely resorbable hernia plug (GORE Bioabsorbable Hernia Plug, made by W. W. Gore & Associates, Inc.) for use as an alternative to permanent devices to reinforce soft tissue in the groin, abdominal, and umbilical regions.

The porous, fibrous structure is composed of a biocompatible and nonantigenic synthetic copolymer that serves as a scaffold for tissue regeneration. It is expected to retain mechanical strength for four to five weeks, and is completely degraded and resorbed over a six-month period.

Use of the device is expected to reduce the potential for chronic complications that have been associated with some permanent plugs such as erosion, migration, and nerve entrapment.

The plug can be cut to fit the defect, and temporarily collapsed for insertion into defects that pass through a major tissue plane. Once the disc expands to fill the cavity, the tubes can be suture-tracked to the sides of the defect for stabilization.

The bioabsorbable hernia plug was previously approved for use in the European Union.

Aortic Catheter (NeuroFlo) Receives HDE for Treatment of Cerebral Ischemia in Acute Vasospasm

On March 30, the FDA approved a humanitarian device exemption for a dual-balloon aortic catheter (NeuroFlo, made by CoAxia, Inc.) for the treatment of cerebral ischemia resulting from symptomatic vasospasm after aneurysmal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management.

The multilumen catheter is introduced via the femoral artery and advanced to the descending aorta, where it redirects blood that is partially restricted from flow by two balloons on the distal tip.

The approval was based on the results of a study in 19 vasospasm patients across three centers located outside the U.S. The study showed that use of the catheter resulted in significant neurologic improvement (National Institutes of Health Stroke Scale score increase of at least three points) in 50% of patients at 24 hours.

Of these eight patients, six demonstrated sustained improvement at 30 days postprocedure. Significant neurologic improvement was also achieved at 30 days in three patients who had not done so at 24 hours.

Use of the device is contraindicated in pregnant women and patients with significant left ventricular dysfunction, aortic aneurysm (including those treated with endovascular grafts), or a history of bleeding disorders.

Humanitarian use devices are intended to benefit patients in the treatment and diagnosis of diseases and conditions that affect fewer than 4,000 individuals in the U.S. per year.

The aortic catheter was approved for use in the European Union in November 2003. It is also currently approved for use in Argentina.

MRI-Safe Paclitaxel- and Sirolimus-Eluting Coronary Stents (Taxus Express 2, Cypher)

On April 5 and April 20, the FDA approved a condition of use for two drug-eluting coronary stents (paclitaxel-eluting stent: Taxus Express 2, made by Boston Scientific Corp.; sirolimus-eluting stent: Cypher, made by Cordis Corp., a Johnson & Johnson company), allowing patients to immediately undergo magnetic resonance imaging (MRI) after implantation of the device.

In the past, patients receiving these metal-containing coronary stents have been required to wait approximately two months before undergoing MRI due to the potential risk of device migration and heating caused by the intense magnetic fields.

The approvals were based on the results of laboratory studies showing the stents to be MRI-safe at a very high level of magnetic field strengths with minimal effect on temperature and drug release.

The drug-eluting stents are indicated for the interventional treatment of coronary artery disease.

Reviewed by Gary D. Vogin, MD

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