Beta Cath System

What is the Beta-Cath System?
The Beta-Cath System is a device designed to reduce the occurrence of an artery renarrowing after angioplasty inside a stent for the treatment on in-stent restenosis.

It delivers a small amount of Beta radiation, a low penetrating form of radiation, locally to the treated area. The radiation is delivered from the Transfer Device to your artery through the catheter. Radiation treatment is intended to inhibit the overgrowth of normal tissue as the healing process occurs following angioplasty or after stent placement.

Overgrowth of normal tissue is thought to be a major factor responsible for renarrowing of the artery after stent placement.

What is In-Stent Restenosis?
In-stent restenosis is the overgrowth of tissue within a stent that causes a significant blockage in the artery that requires a procedure to reopen the narrowing of the stent occurs due to a response by the artery to "heal" the stented area, and this usually occurs within 3-9 months after the stent is placed.

What is Angioplasty?
Angioplasty involves the inflation of a balloon catheter in a narrowed area of your coronary artery. The balloon compresses the plaque (fatty material causing the blockage) against the wall of the artery. This procedure should open the narrowing inside the artery and allow improved blood flow. Angioplasty causes a small injury inside the artery that will heal within a few weeks.

Why should treatment with the Beta-Cath System be considered?
Up to 25% of patients who have stents placed require additional treatment because of restenosis at the stent site. Treatment with the Beta-Cath System is intended to reduce the need for additional angioplasty procedures or surgery due to restenosis or overgrowth of tissue within the stent.

Has this treatment been used before?
Yes, the Beta-Cath System has been used in many patients around the world. Many of these patients underwent an angioplasty procedure and then were treated with Beta radiation, and may have received a stent. Other patients with stents already in place that have restenosed received treatment with the Beta-Cath System.

The Stents and Radiation Therapy Trial (START) showed a reduction in the need for additional procedures for the treatment of in-stent restenosis.

How does the Beta-Cath System work?
After the angioplasty or intervention is performed to reopen the narrowed stent, a Beta-Cath catheter is positioned in the treated coronary artery. This catheter allows temporary delivery of Beta radiation locally to the artery for a precise amount of time, usually 2 to 5 minutes. The size of the artery helps determine the treatment time. When the treatment time is over, the radiation sources and the Beta-Cath catheter are removed. Treatment with the Beta-Cath System adds less than 10 minutes to the total procedure time.

Frequently Asked Questions

What will the Beta-Cath System treatment feel like?
You should not feel any sensation as a result of treatment with the Beta radiation. As with any interventional procedure you may feel some chest discomfort as the catheters are placed within your narrowed coronary artery. This discomfort is temporary and is relieved when the catheters are removed.

What are the risks of Beta Radiation?
There are potential risks associated with radiation of the heart. The dose of radiation to the body is minimal, less than a chest x-ray and much less than that received during a heart catheterization. However, some problems related to the entire procedure could include heart attacks, thrombosis (blood clots in the artery) emergency surgery, stroke or death.

Long-term risks of beta radiation delivered to the coronary arteries are unknown. Clinical trials with the Beta-Cath System show minimal adverse effects up to 8 months after treatment.

What are the treatment alternatives to Beta-Cath System?
You are probably eligible for exercise, diet, and/or drug therapy. However, progression of coronary artery disease may require additional treatment including additional balloon angioplasty, heart surgery, and/or an additional stent placement.

What are the contraindications and precautions?
You should not receive the Beta-Cath System treatment if you are allergic to medications involved with angioplasty (or interventional) procedures. Special consideration should be given to women who are pregnant or suspect pregnancy.

How long is the hospital stay?
Treatment with the Beta-Cath System will add about 10 minutes to your procedure in the Cardiac Catheterization Laboratory. Your hospital stay should be the same as for an angioplasty or stent procedure.

What patient follow-up is required?
Your doctor will see you before you go home and may contact you after the treatment.

Will additional medication be needed?
Based on your physician's judgment for the best course of treatment, you may require additional medication. Some medication may require blood tests. Your doctor will discuss this with you before you go home.