A new paradigm in catheter use and construction for minimally invasive interventional medical procedures
July 29, 2019
New Jersey– Covellus LLC. (Covellus), a medical device company focused on the development of a novel modular catheter systems for interventional procedures, announced today the results from a case study demonstrating the paradigm shifting modular catheter system. The Covellus modular catheter system is a unique approach to the construction and use of catheter devices for minimally invasive surgical procedures. Instead of an integrated construction, 2 modules are combined in the operating room by the physician to create a catheter device tailored to the procedure. The case study describes using the modular system to create a scoring percutaneous transluminal angioplasty (PTA) balloon catheter that would not be otherwise available in a pulmonary valvuloplasty procedure on a canine patient.
As presented in the peer-reviewed paper, Modular Catheter Systems in Minimally Invasive Interventional Medical Procedures: Case Study, the 2 module catheter system consisting of any commercially available PTA balloon catheter and a custom designed scoring adapter were manufactured and successfully used in a minimally invasive veterinary cardiovascular intervention to treat a case of canine subvalvular pulmonary stenosis. The veterinary intervention was performed at Colorado State University’s James L. Voss Veterinary Teaching Hospital (CSUVTH) by Dr. Brian A. Scansen. CSUVTH is unique in the region with a state-of-the-art cardiac catheterization lab for animals and the only veterinary interventional cardiology fellowship program in the world.
As Dr. Scansen explained, “We deal with resistant stenotic lesions in dogs that required scoring or cutting balloon technology for effective dilation; however, commercially available devices are sometimes not large enough in diameter to be effective. This case study demonstrates one advantage of a modular system of this nature where the interventional catheter device can be created in a larger and procedurally appropriate size through the combination of the 2 modules.”
Preliminary use of leading-edge device designs for treating veterinary patients, dogs, prior to human use has a long historical precedent. The publication of this case study in the open access journal, JMIR Biomedical Engineering, which can be accessed here for free (https://biomedeng.jmir.org/2019/1/e14443), follows in that tradition. Covellus believes our modular system as presented will lead a shift in the construction and use paradigm of minimally invasive catheter devices. Modular systems offer improved access to appropriate devices, customization options for physicians, more control over inventory carrying costs and a streamlined pathway for device development and approval. The advantages of modular systems over integrated designs are numerous and with the Covellus system can be translated to medical device catheters.
Covellus, located in the greater New York City area, has patented the first modular catheter system for interventional procedures. Covellus has established a clear pathway for 510(k) clearance of the initial modular catheter products utilizing an attachment mechanism that is universally compatible with all 0.035-inch catheters. Covellus is currently executing on the key high-risk elements required to gain 510(k) clearance for these products. Additional information about Covellus can be found at www.covellus.com