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Compliance In Focus
Posted by John Lehmann on Wed, May 15, 2019

New Medical Device Approved To Treat Brain Aneurysms

brain-aneurysm-deviceApproximately 30,000 people suffer from ruptured brain aneurysms every year in the United States, and about 40 percent of them die as a result, according to the Brain Aneurysm Foundation.

Neurovascular stents are commonly used to treat unruptured brain aneurysms. However, the FDA last year issued guidance to healthcare providers about the risks of using neurovascular stents for stent-assisted coiling, warning that the risks of this treatment may outweigh the benefits for many patients.

The FDA recently approved a medical device designed to treat brain aneurysms by restricting and diverting blood away from the aneurysm, preventing it from growing and rupturing.

Here’s a closer look at how it works and how new treatments like this one could transform the way we treat brain aneurysms.


What Is the New Device?

The device is known as the Pipeline Flex Embolization Device, manufactured by Medtronic.

It is a permanent mesh cylinder (stent) braided from platinum and tungsten and cobalt-chromium designed to treat brain aneurysms that bulge out the sides of a blood vessel. The stent also includes a guidewire-based delivery system to place the implant inside the patient.

The guidewire is inserted into a femoral artery through a small cut in the groin. Then it is guided to the site of the aneurysm and released so it can work by restricting and diverting blood flow.

The FDA approved the device for the treatment of brain aneurysms in patients 22 and older with small or medium-sized aneurysms with a wide neck (2 mm or wider), as well as elongated, spindle-shaped aneurysms involving the entire blood vessel.

The device should not be used in patients with an active bacterial infection, patients who are unable to take blood thinner medications, patients who have not received dual antiplatelet medical prior to the procedure or patients who already have a stent in the artery where the aneurysm is located.

What Are The Results of Clinical Trials?

In a clinical study of 134 patients, 79 percent of patients who were treated with the device achieved a successful outcome. This is defined as complete occlusion of the brain aneurysm within one year after the procedure (without re-treatment) or significant narrowing of the blood vessels.

These early results appear to be promising, although we expect to see more clinical trials forthcoming.

IMARC’s Expertise In Brain Aneurysm Treatments

The IMARC Research team has extensive experience supporting studies involving intracranial aneurysms. In the past five years, we have participated as consultants, monitors or auditors for a number of studies, including:

  • A pivotal study of a self-expanding retrievable stent system in the treatment of wide-necked intracranial artery aneurysms
  • A pivotal study of a flow re-directional device to treat intracranial aneurysms
  • A prospective study on embolization of intracranial aneurysms

These are complicated studies involving complex populations who generally present with multiple comorbidities. Ensuring a well-controlled clinical study for research of this nature requires upfront planning for risks and appropriate mitigation. It requires extensive training of the internal team and the investigative sites, early monitoring and good communication between all stakeholders.

Our experience has taught us many things, including:

  • Having a sponsor representative present for case support for a certain number of subjects at each center can help foster proper technique and reduce the likelihood for protocol non-compliance. Sponsor representatives should be thoroughly familiar with the product, the protocol, and Good Clinical Practice.
  • Because imaging was used to assess primary efficacy, getting subjects back for these tests is of utmost importance. We ran into issues with insurance not covering the six- and 12-month tests even though they were considered the standard of care at the institutions. Planning for the payment of any imaging not covered by insurance may prevent some loss of important data.
  • Some subjects could not undergo some of the imaging later in the study due to contraindications. Writing the protocol to allow for an alternative imaging modality will prevent unnecessary protocol deviations.
  • It can be difficult for the core lab to keep up with the volume of imaging. Assuring that the core lab has the personnel and resources to perform their role on the study is important. Getting a site’s early feedback on image quality can also help prevent issues with future subjects.

We’re excited about advancements in treatment for brain aneurysms, which have the potential to save lives. If you are exploring a new device to treat aneurysms or other medical conditions, we can help you ensure compliance and earn approval.

Contact us today to learn more about our expertise in this area.

History of Clinical Research VIDEO 


Topics: FDA Approvals, medical device trends


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