Cook Medical Introduces Ciaglia Blue Dolphin™ Percutaneous Dilational Tracheostomy Device

The world's first one-step device combines balloon dilation and tracheal tube insertion to reduce risk to patient

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical announced today the availability of the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer, the first device for percutaneous dilational tracheostomy (PDT) procedures that combines balloon dilation and tracheal tube insertion into one step.

“Minimizing the invasiveness of surgical techniques is vital when caring for critically ill patients”

PDT is an elective procedure generally performed on patients in the ICU who require long-term ventilation. PDT is accepted as a safe, cost-effective and reliable bedside procedure; however, patients are still at risk for intraoperative complications, including tracheal trauma. By creating a true one-step device that transitions from dilation to trach tube insertion, the Ciaglia Blue Dolphin has the potential to reduce these complications while also minimizing procedure time from skin incision to tracheostomy tube placement.

“Minimizing the invasiveness of surgical techniques is vital when caring for critically ill patients,” said Dr. Ben deBoisblanc, professor of medicine and physiology, LSU Health Sciences Center. “Employing radial balloon dilation, the Ciaglia Blue Dolphin represents an evolution in percutaneous tracheostomy technique that can potentially reduce risks associated with the traditional procedure, including anterior wall compression and posterior wall injury. The Ciaglia Blue Dolphin simplifies the PDT technique by combining balloon dilation and tracheal tube insertion into one step, shortening procedural time and reducing tidal volume loss.”

The balloon minimizes pressure on the anterior tracheal wall and delivers an even and controlled radial dilation. This significantly reduces the downward force needed to create a tracheal stoma compared to traditional PDTs. Additionally, the device may minimize bleeding, ring fractures and posterior wall perforations by eliminating the need for a dilator to advance back and forth in the trachea, and by limiting soft tissue dissection to a simple skin incision. Due to the “elastic memory” of tissue, the stoma tightly contracts around the tracheostomy tube once the procedure is complete, providing the needed seal and tamponade effect to help prevent bleeding.

"Since 1987, we have worked with innovative physicians and surgeons to improve the safety, economy and convenience of this popular procedure,” says Bruce Gingles, global vice president of Cook Medical's Critical Care strategic business unit. “By introducing the Ciaglia Blue Dolphin, we've produced a device that simplifies these procedures. The product’s beauty lies in its simplicity; it is an uncomplicated and efficient way to perform PDT."

Featuring a nylon construction, the Ciaglia Blue Dolphin balloon measures 5.4 cm long with an outer diameter of 16 mm when fully inflated. The maximum inflation pressure of the balloon is 11 atmospheres (atm).

Availability

The Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer is currently available in the United States. Physicians are required to undergo product training prior to purchase.

About Cook Medical:

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.