Pulmonary Embolisms (PE) – Cook Medical’s Next-Generation (IVC) Filter Delivery System

This week Cook Medical participated in the Transcatheter Cardiovascular Therapeutics Convention in San Francisco where they announced a new product line to combat and prevent pulmonary embolisms. PEs are the #1 cause of in-hospital deaths, affecting 600,000 Americans every year, and resulting in 200,000 deaths (that’s more than breast cancer, AIDS and car accidents combined).

Before the conference took place, I had a few minutes to speak with Mark Breedlove, Director of Cook’s embolization, filters and renal technology Unit about the product use and about pulmonary embolisms. PE (pulmonary embolisms) are a secondary condition in many instances with other surgeries, in other words having knee surgery as an example could be risky if there are a blood clot located somewhere in the body that could cut loose and end up going to the lungs.

In such a situation where a surgical procedure is being conducted, the Vena Cava filter is left in place for 2 weeks, and the patient comes back in around 2 weeks to have it removed. Mark also stated that sometimes patients don’t come back and the filter is left in place. I asked if there was any danger in this, and he stated it was minimal.

I asked how wide spread is this procedure, is it common? Mark stated that most trauma centers in the US do in fact have filters from Cook Medical, to be prepared for this type of procedure, otherwise a simple surgical procedure could be deadly if blood clots go without being monitored.

The NavAlign delivery system is used to put the filter in place. The filter is made of a non magnetic material and is also seen by and MRI. Insurance covers the placements as part of the procedure in most instances. The patient is evaluated prior to surgery to see if there are any potential clots in their system where the filter is needed.

Is this a lengthy procedure that adds additional time to the surgery? Mark stated that the Interventional Radiologist is the physician who performs the procedure and normally it is done within 8 minutes. Earlier this year I had the opportunity to speak with the new strategic business unit at Cook, focusing on Interventional Radiology.

Cook Medical Announced the new Strategic Business Unit – Interventional Radiology

Interventional Radiologists are one of the best kept secrets in healthcare. The Interventional Radiologist is board-certified physicians who specialize in minimally invasive, targeted treatments. For example, they use imaging to advance catheters through our bodies, thus offer us, the patients alternatives to major surgeries with the techniques developed.

Mark also told me that Cook is also training other surgeons, such as orthopedic surgeons on how to do the procedure as well. This could come in handy if an Interventional radiologist was perhaps not available. Cook Medical with the use of the IVC filters promotes the use of “pro-active” medicine, in other words, not subjecting patients to risk where blood clots could endanger lives without the use of the filters. If you find yourself in a trauma center, or even just having a knee replacement and IVC filter could be part of your surgical procedure. BD

Press Release:

Cook Medical’s Advanced NavAlign™ Delivery System for IVC Filters Adds

Procedural Speed, Control and Accuracy

New Design Simplifies Jugular Deployment, Minimizes Trauma, Compatible with Full Line of IVC Filters

SAN FRANCISCO, Calif., September 23, 2009 – Physicians can now navigate even the most tortuous anatomy with greater speed and safety with the next-generation inferior vena cava (IVC) filter delivery system introduced today by Cook Medical at TCT 2009. The release of the NavAlign™ delivery system marks the 20^th anniversary of Cook’s first IVC filter and further advances the treatment of pulmonary embolism (PE), a life-threatening condition caused by blood clots in the lungs that affects thousands of Americans annually.

"PE is responsible for more deaths every year than AIDS, breast cancer and motor vehicle accidents combined, and demands more advanced and effective treatment options to improve patient outcomes," said Mark Breedlove, director of the vascular therapies technology unit of Cook Medical. "Cook has been perfecting its IVC filter platforms for the last three decades, a milestone underpinned with the introduction of NavAlign. We hope our pedigree in this area, and continued commitment to innovation, will encourage more physicians to adopt our platforms and procedural products to reduce the risk of recurrent PE."

PE occurs when a blood clot dislodges from the wall of a vein and migrates to the lung, where it blocks blood flow in the pulmonary artery. It is often a deadly complication of venous thromboembolism (VTE), clots in the veins that typically occur in patients immobilized by disease, injury or relatively minor surgeries like knee replacements and gastric bypass. Untreated, these clots will kill one out of three individuals. Positioned in the main vein that collects blood from the lower part of the body, IVC filters are designed to catch the blood clots before they get to the lungs. Traditionally they are placed using fluoroscopy by threading a catheter guided through the veins.

The NavAlign delivery system, available for both the Cook Celect® and Günther Tulip™ filters, is designed to minimize trauma and streamline filter placement with features unavailable on any other existing deployment system. A hemostatic valve minimizes blood loss at the point of entry, while a multipurpose dilator has radiopaque sizing bands and flushing sideports that decrease fluoroscopy time and the amount of contrast medium required.

Since 1989, when Cook brought the Bird’s Nest® IVC filter to the U.S. market, Cook products have helped to prevent PE in more than 200,000 patients.

“Our efforts to prevent PE span the entire scope of the procedure, from accessing the vessel with our introducer sets and needles to targeting the location of the filter with our catheters and wire guides to successfully preventing the incident with retrievable or permanent filters,” said Breedlove. “The NavAlign delivery system is a natural overlay to this procedural approach, and we look forward to improving the prevention of PE thanks to this groundbreaking technology."

About Cook Medical
Cook Medical helped invent and popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures throughout the body’s vascular, gastrointestinal, respiratory, urological and OB/GYN pathways. 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 radiology; critical care medicine; gastroenterology; peripheral vascular medicine; bone access and oncology; interventional cardiology; general surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963, Cook Medical operates as a family-held private corporation focused on providing superior patient outcomes while reducing health care delivery costs. For more information, visit www.cookmedical.com

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