MedClose™
MedClose™ is an investigational-stage* vascular closure system (VCS) that is intended to seal the femoral arterial puncture site following cardiac or peripheral diagnostic or interventional procedures as well as interventional radiological and carotid stenting procedures. CPC is pursuing worldwide commercial applications for the MedClose™ VCS.
CPC has also filed a patent application for its synthetic sealant sealant for its specific application to the MedClose™ VCS.
The Need
Many of today’s lifesaving interventions require catheterization. In order for the healing process to begin following such a procedure, the vascular wound must be closed and the patient’s bleeding halted. The number of catheterizations requiring vascular closure worldwide surpassed 14 million in 2007, and is expected to reach 17.6 million by 2013.** MedClose™ VCS is intended to fill the growing need for a safe, reliable closure system that can reduce a patient’s time to hemostasis, enable faster ambulation and, when necessary, allow for easy wound re-access.
Future Applications
CPC is presently focused on the development and testing of the MedClose™ VCS for use in percutaneous intravascular diagnostic and interventional procedures but will also design and develop new vascular closure applications based upon a broader range of French sizes (i.e., introducer sheath diameters). The MedClose™ VCS design has the capabilities to be rapidly adapted to not only focus on its core VCS application for vascular closure following diagnostic or interventional procedures (coronary, carotid, cerebral, peripheral) with 6-9 French (Fr) catheters but also for:
4-5Fr for applications such as vascular closure following catheterization procedures in pediatric populations, closure of central line access points for chemo-therapy patients, hemostasis after arteriovenous fistulae access and peripheral arterial and/or venous closure after diagnostic and interventional electrophysiology procedures.
10-12Fr for applications such as iliac and abdominal aortic aneurysm (AAA) stent/graft implants.AAA stent/grafts
15-20Fr for applications such as existing designs for percutaneous aortic and mitral valve replacement, endovascular stent grafts.
Importantly, the synthetic sealant and its characteristics also have potential future applications such as internal and external bonding and coating of tissue and instruments, (e.g., temporary coatings for burn victims, grafting of artificial skin, adhesion prevention, coatings on polymers, or coatings on implant devices such as stents or grafts, and biopsy sealing) with or without drug delivery (e.g., the delivery of glucosamine and chondroitin sulfate into the spine area or other body organs), stem cell or growth factor delivery (e.g., the delivery of stem cells and/or growth factors into the spine area or other body regions), tissue sealants/adhesives to control of bleeding or fluid leakage in body tissue (e.g., lung sealing or hemostasis, tissue, muscle, and bone growth and regeneration), and dermatology (e.g., collagen restoration/replacement, topical application or void-filling by injection to fill wrinkles).
We believe that our sealant offers some important potential advantages over other sealants in several respects. First, as a synthetic sealant, our product is free from the risk of blood-borne and other pathogens. Second, testing to date indicates excellent adhesive strengths when applied to wet areas of tissue which could offer a tremendous competitive advantage due to the fact that vascular closure sites are normally initially wet due to the presence of blood or body fluids. And finally, the synthetic sealant appears to perform independently with respect to the level of anti-coagulation present.
We believe the MedClose™ VCS System has the potential to represent multiple product lines in multiple market segments, enhancing the value to such intellectual property. We continue to improve the MedClose™ VCS by strengthening the platform of regulatory, quality, and manufacturing capabilities for new product development and sustaining engineering.