PITTSBURGH--(BUSINESS WIRE)--CardiacAssist Inc. announced today that it has introduced a longer cannula set to cardiologists and cardiac surgeons to be used with its TandemHeart® cardiac-assist device: “TandemHeart Transseptal Cannula Set—Enhanced Flow 72” (THTC-EF 72).
The TandemHeart® System is the only percutaneous “extracorporeal circulatory support” device approved by the FDA for sale in the U.S. and is now being used in 100 of the elite cardiac centers across the United States. All other heart assist devices are labeled by the FDA to be used for “partial circulatory support” because of their limited capacity to pump blood. On the other hand, the TandemHeart device is FDA-cleared for circulatory support for critically ill patients and can be placed rapidly in a cath lab or an operating room. In addition, the TandemHeart System is fully reimbursed by Medicare under existing DRG codes.
“Percutaneous access allows implementation of mechanical support in minutes, rather than hours, as is the case with more invasive systems,” said Michael Garippa, Cardiac Assist’s CEO. “The TandemHeart cannulae are specially designed to accommodate various patient sizes and to permit appropriate flows at various pump speeds, which makes the TandemHeart System the most versatile cardiac-assist device available today.”
The new TandemHeart Transseptal Cannula Set-Enhanced Flow 72 (THTC-EF 72) provides extended length to enable cannulation in individuals with a longer torso and also accommodates the increased distance to the left atrium when cannulation is necessary from the left femoral vein. The new THTC-EF 72 is 10 cm longer than the standard TandemHeart Transseptal Cannula—EF and also includes a sealed pouch with two adjustable suture rings.
Following standard transseptal puncture and hole dilation using a two-stage dilator, the standard- or extended-size cannula is advanced through the femoral vein into the left atrium. The curved design at the distal end of the cannula body facilitates optimal placement of the tip in the left atrium. Centimeter markings at the proximal end of the cannula are used to record the location of the cannula at placement, and also serve as a visual aid for monitoring any change in location—which could occur when the patient is moved. Distal tip and side holes are configured to allow adequate blood flow and drainage of the left atrium. Radiopaque disks are located in the tip of either the standard or extended cannula for visualization under fluoroscopy.
Also of note: the obturator has a short, tapered tip for ease of insertion. A standard-locking luer connector at the proximal end of the obturator allows attachment of a hemostasis valve for dye injection, pressure measurement, or blood sampling. Commercially available wire-reinforced arterial cannulae are used to return the blood into the patient’s systemic circulation by way of the femoral arterial system.
To date, the TandemHeart System has been used in 30 countries at 130 different cardiac care facilities by 320 different physicians: both cardiologists and cardiac surgeons.
Contact:
Ronald Trahan Associates, Inc. Ron Trahan, APR, 508-359-4005, x108
