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What is a PFO?What is an ASD?What is a VSD?
Will I be awake during the procedure?
How does the implant stay in place?
What does the implant look like?
What are the risks?
Will the procedure hurt?
What is the special care after the procedure?
What about follow-up visits?
Does the implant stay in for the rest of my life?
Can I go through metal detectors, or have an MRI?
What are the options or alternatives to this treatment?
What are the contraindications to this treatment?
What is the bioabsorbable material?
Has this material been used in humans before?
Some patients may have general anesthesia if a physician is using Trans-esophageal Echocardiography (TEE) during the procedure. If the physician is using Intracardiac Echocardiography (ICE), general anesthesia is not required. A local anesthetic will be used to numb the groin or neck (the location where the catheters are inserted).
BioSTAR®, STARFlex®, and CardioSEAL® are made from two small diameter wire frameworks with either a bioabsorbable collagen material or a surgical polyester mesh matrix attached to it. The device looks like two little umbrellas set edge to edge. Each umbrella framework has springs that help the umbrellas to seal the septal defect. This very slight tension, along with the blood in the heart, holds the implant in place. Over time the collagen component of the BioSTAR® implant is replaced by healthy natural heart tissue. The remaining wire frame work will be enclosed with tissue. With STARFlex® and CardioSEAL® the surgical polyester mesh matrix is a biocompatible material that allows tissue ingrowth, to seal the defect over time.
The implants come in several sizes. The framework is made from a metal alloy, frequently implanted in the body during other surgeries, shaped in a X. The bioabsorbable collagen material (used in BioSTAR® ) is very thin, almost transparent, and similar to material some physicians would use to promote wound healing or repair other defects. The surgical polyester mesh matrix used in CardioSEAL® and STARFlex® consists the same material implanted for many surgical repairs and is a biocompatible material that allows tissue ingrowth, to seal the defect over time.
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Usually not. After the procedure, some patients report tenderness at the groin or neck. Some may also complain of a sore throat from the Transesophageal Echocardiography (TEE) probe. Patients cannot “feel” the implant.
Patients are asked to see their doctor for follow up visits. The physician will provide specific instructions for follow-up care.
Yes. CardioSEAL® and STARFlex® will have tissue growth over the implant. BioSTAR® is the only implant currently available where 90% to 95% of the implant is absorbed and replaced by healthy tissue. The small metal frame work will remain.
Yes. The implant will not set off metal detectors. The metal framework is not magnetic. It will not be affected by an MRI procedure; the pictures taken may have a fuzzy quality near the location of the implant. If an MRI is needed, the MRI staff should be informed about the presence of the implant.
Having open heart surgery to close the shunt is an option. Continuing to take medications is also an option. Or, you may elect to have no treatment of any kind.
The material used to create BioSTAR® is a biological matrix from porcine intestinal collagen layer, sometimes referred to as ICL. The material is purified to remove all non-collagenous components such as cells, cellular debris, nucleic acids, lipids and other extracellular matrix proteins.[2] The layers are then cross linked together giving the implant strength and conformability.[1]
Yes. ICL is FDA approved for medical use in the United States. BioSTAR® has the СE Mark in Europe and is approved in Canada. Several thousand implants for soft tissue repair have been performed.[3] [4] [5] Extensive testing has been performed on this material.[1] [2]
[1] Jux C, Wohlsein P, Bruegmann M, Zutz M, Franzbach B, Bertram H. A New Biological Matrix for Septal Occlusion. J Interv Cardiol 2003; 16:149-152.
[2] Jux C, Bertram H, Wohlsein P, Bruegmann M, Paul T. Interventional Atrial Septal Defect Closure Using a Totally Bioresorbable Occluder Matrix: Development and Preclinical Evaluation of the BioSTAR® Device. J Am Coll Cardiol 2006;48:161-169.
[3] Badylak SF. Xenogeneic extracellular matrix as a scaffold for reconstruction. Transplant Immunol. 2004;12:367-377
[4] Franklin ME Jr, Gonzalez JJ Jr, Glass JL. Use of porcine small intestinal submucosa as a prosthetic device for laparoscopic repairs of hernias in contaminated fields: 2 year follow-up. Hernia. 2004;8:186-189
[5] Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vas Surg.2005; 41:837-843.
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"Over time the BioSTAR® scaffold will be replaced with the patient's native tissue."
Michael J. Mullen, MB, BS, MRCP, MD, Consultant Cardiologist, The Heart Hospital, London, United Kingdom