Research Explores a Disappearing Heart Scaffold (Stent) That Helps Your Artery Without Permanent Metal.

Many patients with blocked arteries are anxious about getting permanent stents. We’re leading clinical trials—backed by two decades of research—for a temporary device made of magnesium that vanishes in 12 months. 

When my patients need a procedure to open a blocked heart artery, they often ask if the metal implant called a stent has to stay in their body forever. Traditionally, the answer is yes. 

Thanks to decades of research, much of it led by MedStar Health Research Institute, we’re on the cusp of a breakthrough: a temporary scaffold that supports your blood vessel as it heals and then disappears when it’s no longer needed. While the device is still being evaluated in clinical trials and is not yet available as standard treatment for marketing, researchers hope it will offer another option for patients in the future.

To open a blocked or narrowed artery (coronary artery disease), we traditionally use a minimally invasive procedure called angioplasty, or percutaneous coronary intervention. First, we thread a tiny tube called a catheter through a small incision via the wrist or the groin and into the heart’s blocked blood vessel. There, we open the vessel by inflating a tiny balloon and place a metal stent, which looks like a mesh tube, inside the artery to keep it open. 

Metal stents save lives by restoring blood flow to the heart. But stents keep that segment of artery rigid. Ideally, an artery should be able to naturally expand and contract as blood flows through it. A permanent metal stent can limit that flexibility. As with any permanent implant, there is a small risk of complications with stents long term.

To help solve these problems, we’re leading clinical trials to examine a temporary option: a scaffold made of magnesium that holds your artery open while it heals, then completely resorbs within 12 months. The results could lead to a major shift in heart care by giving patients an option that supports healing without leaving a permanent implant behind.

Why leaving nothing behind matters to your health.

Modern stents are safe and effective, and they have helped millions of patients. However, researchers have long explored whether there might be advantages to a temporary device that supports the artery while it heals and then disappears.

In addition, some patients may feel uncomfortable living with a permanent metal implant inside their body. While rare, some complications of having a stent include:
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• Chronic inflammation: Metal in the body can trigger inflammation in some people

• Blood clots: These can form inside the stent, possibly blocking blood flow

• Imaging interference with CT: Metal can cause shadows and other distortions that can complicate future imaging.

• Reclogging: Scar tissue can form inside the stent, making the blood vessel narrow again

The bioresorbable magnesium scaffold is a game changer. Made from natural magnesium, the scaffold provides strong structural support for the blood vessel. As your blood vessel heals, the scaffold breaks down and is safely absorbed by your body.

How the dissolving scaffold works.

The temporary magnesium scaffold supports your artery in three main steps:
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1. Immediate support: We use the same minimally invasive catheter-based procedure to place the scaffold in your balloon-opened artery to widen the vessel and restore normal blood flow to your heart.

2. Gradual healing: Over 12 months, the scaffold provides the necessary structure while the natural material it’s made from slowly dissolves inside your body.

3. Restored movement: Once the scaffold is fully absorbed, there’s no hardware left in your blood vessel, allowing it to flex, widen and contract, and function normally.

As a heart doctor, I must state that the dissolving scaffold technology is only part of the heart health solution. Taking your medications, managing your blood pressure, and adopting heart-healthy habits can help your blood vessels stay clear and healthy in the long term. 

Testing the technology: Ensuring safety through the BIOMAG 3 study.

Rigorous clinical testing is essential before this technology can become widely available. To make sure this dissolving technology is as safe and effective as a traditional stent, we’re leading a research study called BIOMAG 3. In this clinical trial, more than 1,800 people at 120 sites worldwide will be randomly assigned to get either the magnesium scaffold or a metal stent. 

Researchers will follow up with these patients over the next year to study how well the new option compares. If it’s effective and safe, and if it gains approval from the Food and Drug Administration, the magnesium scaffold could be a new option to treat coronary artery disease.

For nearly two decades, physician investigators from MedStar Heart & Vascular Institute, supported by MedStar Health Research Institute, have helped evaluate this technology from early laboratory studies through global clinical trials. Because we were the first institution in the U.S. to use the magnesium scaffold and the first center to enroll patients in the BIOMAG 3 trial, our team brings deep experience to every procedure. 

My colleagues and I are excited to be leading the way because this technology has the potential to restore normal blood flow while allowing the artery to heal naturally over time.