The discussion and conclusions presented in this document are based on the results of preclinical studies and are not intended to represent any approved or commercially available device(s).
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CoreoGraft® – Coronary Artery Bypass Graft
Presently, there are no FDA approved grafts for coronary artery bypass procedures. Various medical device and tissue engineering research groups and companies have attempted to develop a small diameter (less than 4 millimeters, about 3/16 of an inch) vascular graft for coronary artery bypass procedures. In some instances the results of these efforts have yielded devices with theoretical promise but with little practical success. This is mostly due to the fact that problems associated with small diameter conduits, such as thrombosis and kinking.
The CoreoGraft® is both anatomically and functionally similar to saphenous vein grafts and has been demonstrated in first in human studies to sustain effective “coronary” hemodynamics and cardiac function.
More than 500,000 coronary artery bypass grafts (CABG) are performed each year in the United States alone, and that number is expected to increase with an aging population. However, as a result of improved surgical safety and outcomes in older patients, redo/surgical procedures and patients with serious comorbidities (e.g., end stage renal disease, diabetes) often have a lack of accessible or adequate vein for the bypass. The following profiles exemplify this population:
- Patients who have experienced previous CABG surgery and need multiple vessel redo surgery; the internal mammary artery is not available and previous surgery harvested most of the leg veins.
- Patients who have had previous bilateral vein stripping or harvests and require multiple bypass grafts.
- Patients on chronic dialysis with previous CABG surgery with poor or no available leg veins and the internal mammary artery used in conjunction with the first procedure; because of hemodialysis radial arteries cannot be used.
- Patients with amputation of one or both legs and previous CABG surgery.
- Elderly female patients with diabetes and previous CABG surgery requiring multiple vessel bypass; for many of these patients only one internal mammary artery is usable since the use of the second internal mammary artery is attended by a high risk of sternal complications.
- Patients presenting for either a first or redo CABG procedure with veins that are not suitable because of previous saphenous vein thrombosis or trauma to the veins during harvest.
- Patients with previous CABG surgery utilizing vein grafts who suffer serious accidents during coronary angioplasty or other coronary catheter procedures and require immediate multiple vessel bypass.
The CoreoGraft® Bioprosthesis for coronary artery bypass grafting; the 3mm internal diameter bioprosthesis is provided in 20cm lengths.
First in Human Clinical Studies
Outcomes of 24 procedures performed by Dr. Wade Dimitri and colleagues at Walsgrave Hospital, U.K., exemplify the utility of the CoreoGraft® bioprosthesis as an alternate or supplemental coronary bypass graft. This preliminary clinical study was limited to patients without sufficient available autologous grafts or in instances when the patient could not be weaned from bypass perfusion because of incomplete cardiac revascularization. Twenty-six bioprostheses were implanted as coronary artery bypass grafts in 24 patients requiring a complete myocardial revascularization subsequent to hospital admission for coronary artery bypass grafting. In all cases, the bioprosthesis was used when it was determined that adequate or suitable autologous conduits were not available as a consequence of prior use, vascular pathology or contraindication associated with a comorbid condition. The recipient population consisted of 17 males and 7 females with a mean age of 74 and 76, range 65-84 and 63-90, years respectively. The vast majority (21/23) presented with at least three-vessel disease and were generally New York Heart Association functional class three or four; ejection fraction was good in 45 percent, fair in 45 percent and poor in 10 percent of the cases; two patients required concomitant aortic valve replacement. The CoreoGraft® bioprostheses represented 35 percent of the seventy-four bypass grafts which included 14 pedicle and one free left internal thoracic artery grafts. Hospital mortality was 17 percent, with the remainder of the patients discharged in good condition; no mortality was associated with bioprosthetic failure. The initial results demonstrated that the CoreoGraft® bioprosthesis supports adequate coronary flow and maintains cardiac perfusion.