Two Cook Technologies Move Forward

Press Release

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 20th 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 . You may sign up to follow Cook Medical on Twitter at .

Source: Cook Medical

Press Release

CIRSE, Lisbon – September 21, 2009 - In a breakthrough development that could dramatically reduce the number of leg amputations and painful bypass graft surgeries performed annually on European patients, a first-of-its kind drug-eluting stent for a widespread form of peripheral arterial disease (PAD) is now available to physicians throughout the European Union.

Created by Cook Medical, a world leader in minimally invasive medical device technology for superior patient outcomes, the new CE Marked Zilver PTX Drug-Eluting Peripheral Stent is widely expected to improve the standard of care for many patients with serious blockages in the superficial femoral artery (SFA) by creating a highly effective, completely new treatment option.

In the largest clinical trial of its kind ever conducted, the Zilver PTX stent was shown to effectively bridge the gap between the patient results achieved using open surgical bypass graft procedure - which is typically more painful and requires a longer hospital stay for the patient - and the less traumatic, but typically less effective, earlier minimally invasive treatment options for PAD such as balloon angioplasty and bare metal stenting[1].

“With the Zilver PTX stent, Cook has introduced a true landmark device that can reduce the number of PAD patients having to endure the trauma of leg amputations and bypass surgeries,” explained Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “Clinically proven, polymer-free and exceptionally durable, we expect the Zilver PTX stent to become the new standard of care for PAD in the SFA.”

Cook’s revolutionary device will be introduced commercially to European physicians at the annual CIRSE meeting, held this year from September 19-23 in Lisbon. The launch includes several important developments, including the introduction of a new website, http://www.cookmedical.com/zilverptx, with clinical and practical information on the device for patients and physicians in English and major European language languages, and a Twitter page for live updates from CIRSE, http://www.twitter.com/ZilverPTX.

Cook also has initiated a first-of-its-kind open clinical database on SFA treatments. The SFA Open-Registry provides physicians with an opportunity to exchange ongoing, real world treatment results. Utilizing an intuitive web interface, clinicians may track their patients, view the medical community’s trends in treating PAD and determine the most effective treatment options. Transparency will be a central objective of the SFA Open-Registry, with results for all treatment types available to participating physicians.

Another key breakthrough is Cook’s commitment to a patient-focused strategy that should make the device available to virtually any PAD patient who needs it, Lyles explained. As part of its ongoing corporate mission to help reduce global health care delivery costs, Cook has adopted a unique ‘affordable innovation’ strategy aimed at reducing any potential financial or reimbursement barriers to its widespread adoption as the standard of care for PAD in the SFA.

The first drug-eluting stent approved for treating PAD in the superficial femoral artery (SFA), the difficult-to-treat, largest blood vessel in the leg, the Zilver PTX stent first expands and holds open the artery to restore blood flow. The device then delivers the drug paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming. In a major advance over previous drug-eluting technologies, the Zilver PTX achieves targeted drug delivery without using a polymer to adhere the drug to the stent body. This eliminates the potential patient risks associated with polymer-coated devices, including clot formation and inflammation.

Cook licenses the rights to use paclitaxel on peripheral stents and other noncoronary medical devices from Angiotech Pharmaceuticals, Inc., of Vancouver, British Columbia, Canada (www.angiotech.com, NASDAQ: ANPI, TSX: ANP). In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale at this time.

About PAD

Peripheral arterial disease (PAD), or peripheral vascular disease, is caused by atherosclerosis – the build up of fatty deposits (atheroma) within the lining of the arteries. The most common symptom of PAD is leg pain during exercise. Over time the arteries may narrow due to atherosclerosis, resulting in a reduction in blood flow. Severely reduced blood flow in the limbs is also known as critical limb ischaemia (CLI). It is characterized by leg pain at rest, non-healing wounds and gangrene and may lead to amputation of the limb.

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 . You may sign up to follow Cook Medical on Twitter at .

Source: Cook Medical