Kyoto, Japan – Matthew T. Gettman, M.D., program director of the Mayo Clinic’s Department of Urology, has been awarded the 2011 Arthur D. Smith Endourology Lectureship. The award, known as the “Arthur” award, was given at the 29th World Congress of Endourology (WCE) in Kyoto, Japan, this week. Gettman was chosen specifically for his academic contributions to the field of urology, particularly his extensive research and expertise in the fields of robotic and laparoscopic surgery. The Endourological Society’s awards committee presents the Arthur award each year, and Cook Medical sponsors the award in honor of the lifetime achievements of Dr. Arthur D. Smith.
Dr. Gettman trained in urology at the Mayo School of Graduate Medical Education before completing a endourology fellowship at the University of Texas and training in Austria and France as a Mayo Foundation Scholar. Since then, Dr. Gettman has authored more than 250 publications, including 128 peer-reviewed articles, and is currently an active member of the American Urological Association, the American College of Surgeons and the Endourological Society.
Dr. Gettman has been heavily involved in the development of natural orifice translumenal endoscopic surgery and has an ongoing interest in expanding minimally invasive techniques, particularly in the field of robotic surgery, with the goal of improving patient outcomes beyond that which current techniques can accomplish.
“It is a true honor for me to be given the Arthur award,” said Dr. Gettman. “Dr. Smith is the father of endourology and a true innovator in the field. I am humbled to have my name associated with his. In recognition of the award, I sincerely thank my endourologic teachers and colleagues that have helped me in my career.”
“Cook is pleased to congratulate Dr. Gettman on receiving the Arthur award this year,” said Jean-Marc Creissel, global leader of Cook Medical’s Urology business unit. “Dr. Gettman is thoroughly deserving of this award and it is an honor for our company to sponsor physicians that have their eyes set on the future of urology.”
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR and @cookuro.
Bloomington, Ind. – Beginning January 1, 2012, Cook Medical’s central venous catheters (CVCs) will be available to the members served by Novation, the supply contracting company for more than 30,000 members of VHA Inc., UHC, and Provista. This expands nationwide access to these devices through one of industry’s leading health care supply contracting companies.
The contract includes access to Cook’s comprehensive CVC product offering, including Spectrum® minocycline and rifampin impregnated catheters.
“We are pleased that our relationship with Novation continues to grow as we add another business division to its distribution network,” said Dan Sirota, vice president and business unit leader of Cook Medical’s Critical Care and Interventional Radiology divisions. “Our Spectrum central venous catheter sets have been shown to minimize the risk of catheter-related bloodstream infections (CRBSIs). Cook is proud to partner with Novation in delivering a technology that helps prevent dangerous and potentially fatal infections and reduces health care costs to its expansive network of health care providers.”
An estimated 78,000 patients are infected with CRBSIs in the U.S. annually with an average cost estimated at $16,550 to treat per infection.¹ Two decades of evidence, including more than 21 peer-reviewed studies and meta-analyses, confirm that minocycline and rifampin catheters are the most effective tool available to prevent CRBSIs. In addition, Spectrum CVCs meet the newly released recommendations from the CDC for reducing CRBSI if maximal sterile barrier precautions haven’t helped a facility reach its goal.²
About Novation
Founded in 1998, Novation is the leading health care supply contracting company for more than 25,000 members of VHA Inc. and UHC, two national health care alliances, and 5,500 members of Provista, LLC, representing more than 30,000 sites. Novation provides alliance members sourcing and information and data services. Based in Irving, Texas, Novation develops and manages competitive contracts with more than 600 suppliers. VHA, UHC and Provista members used Novation contracts to purchase approximately $40 billion in 2010.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @cookmedicalpr and @cookcriticalcre.
¹ Department of Health & Human Services, Vital Signs: Central Line-Associated Blood Stream Infections – United States, 2001, 2008, and 2009: 2011. Washington, DC: Centers for Disease Control
² O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011;39(4 suppl 1):S1-S34.
Limerick, Ireland – Cook Medical’s valuable place among the business community in Limerick has been recognised by Limerick Chamber at the inaugural Limerick Region Business Awards with Cook Ireland winning Company of the Year and Best Foreign Direct Investment Company at the award ceremony on Friday, October 21.
Presented by Maria Hinfelaar, President of the Limerick Institute of Technology, the Company of the Year Award recognised 16 years of continuous manufacturing growth at Cook Medical, a strong record and commitment to research and development, and the establishment of a European Shared Services Centre that has ensured the Limerick plant has become an integral part of Cook’s global operations.
Attended by the Minister for Jobs, Enterprise and Innovation, Richard Bruton, the Awards celebrate the successes of Limerick businesses from all sectors and company sizes, highlighting their business achievements, innovation and excellence.
Bill Doherty, Exec Vice President, EMEA Cook Medical says, “Winning the inaugural Limerick Region Company of the Year Award is a tremendous recognition of Cook Ireland’s collective effort of over the past 16 years to become a key part of Cook Medical’s global operations and a leading medical device company in the Limerick and the Mid-West region. Our development from a manufacturing and research and development operation to the establishment of a European Shared Services Centre has created exciting and stable job growth of which we are immensely proud and we look forward to continuing our expansion in the coming months and years.”
Established in Limerick in 1996, Cook Medical’s Irish operation has grown from eight employees to over 630, becoming one of the leading medical device employers in the country, accounting for more than 10% of Cook Medical’s output to global markets.
Cook Medical designs and manufactures specialist medical devices used for minimally invasive surgery. The devices are typically used by surgeons, consultant physicians and other specialised medical personnel to treat a wide range of medical problems from Peripheral Arterial Disease (the build-up of fatty deposits within the lining of the arteries), to kidney stone removal and IVF treatment.
Serving medical specialities such as Endoscopy, Women’s Health, Urology, Interventional Radiology and Peripheral Intervention, Cook Medical has brought many ground-breaking technologies and products to market including the Zilver PTX Drug-Eluting Stent. A dedicated research and development team has built a strong relationship with local education institutions such as the University of Limerick, offering work experience opportunities and funding for collaborative research.
Cook Medical is recognised as one of the leading medical device companies operating in the country, which has now become a hub in Europe for the Med Tech industry. Cook is committed to continuing development of its Ireland operation based in Limerick, providing exciting, challenging and stable employment and further establishing Ireland’s stronghold in the European and Global marketplace.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR.
Cook Medical announced today that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA). This new stent expands palliative care options for patients experiencing issues associated with malignant gastric outlet obstruction (GOO), a late stage complication of a variety of GI related cancers with pancreatic cancer being the most common cause.¹ Studies indicate that as many as 50 percent of the malignancies involving the small intestine, including pancreatic, gastric, duodenal and cholangiocarcinoma, occur in the duodenum,² the part of the small intestine connected to the stomach. The stent offers these patients a minimally invasive alternative to relieve the symptoms and potentially life-threatening complications resulting from duodenal obstruction, such as abdominal pain, vomiting, malnutrition and aspiration.
The Evolution Duodenal Controlled-Release Stent, the only duodenal stent delivery system that allows for controlled release and recapturability, is designed to provide physicians with precise control and maneuverability to ensure proper placement and potentially reduce complications such as migration and perforation. The Evolution Duodenal stent is uniquely designed with 18 crowns at both the distal and proximal ends, which allow the stent to adapt to the natural curvature of the anatomy. The proximal and distal flanges are designed to reduce the risk of stent migration, while the patented Flexor® catheter with kink-resistant technology provides trackability and maneuverability for deployment in the difficult anatomy of the duodenum.
“The Evolution duodenal stent includes several product features that are designed to make stent placement easier and more precise for the physician,” said John G. Lee, professor of clinical medicine at the H.H. Chao Comprehensive Digestive Disease Center at University of California Irvine Medical Center. “These features of the stent allow for better wall apposition and potentially reduce the risk of migration, both of which are essential when treating patients with gastric outlet obstructions.”
In a prospective multicenter European study of 23 patients, 21 patients had significant improvement of symptoms.³ No early or late complications were recorded after a median follow-up of 8.8 weeks. Twenty-one patients (91.3 percent) were able to tolerate oral intake with a significant improvement of GOOSS (gastric outlet obstruction scoring system) score. Preliminary conclusions from researchers stated that the Evolution duodenal stent provided effective palliation for malignant gastric outlet obstruction. Additionally, physicians have now completed enrollment of 110 patients in a separate ongoing prospective multicenter study and final analysis of data is presently underway.
“The design of the stent and delivery system with recapturability make it easier to deploy in hard-to-reach areas such as the distal duodenum,” said Dr. Willis Parsons, medical director of the Northwest Community Hospital Gastroenterology Center. “The stent platform is designed for optimal trackability and maneuverability in difficult angulations, providing superior stability at crucial points during delivery.”
“The Evolution duodenal stent provides physicians with highly accurate stent placement, reducing the risk of migration, perforation and minimizing the need for repeat procedures,” said Barry Slowey, global business unit leader for Cook Medical’s Endoscopy division. “We’re excited to be expanding our line of Evolution stents by bringing to the US market a stent platform that aids physicians and has been available globally for several years. This stent has been used to treat thousands of patients around the globe, potentially improving quality of life for these patients, and hopefully minimizing the painful symptoms associated with this disease.”
Available for immediate delivery in the U.S., the Evolution duodenal stent extends Cook Medical’s line of Evolution products for the treatment of gastric diseases.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @cookmedicalpr and @cookgastro.
Dr. Parsons is a paid consultant for Cook Medical.
¹ Frech EJ, Adler DG. Endoscopic therapy for malignant bowel obstruction. J Support Oncol 2007;5(7):303-10, 319. Gastroenterol 2010;45(10):1217-22.
² Small intestine. In: Edge SB, Byrd DR, Compton CC, et al., eds. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer, 2010:127.
³ Hatfield AR, Giovanni M, Siersema PD, et al. Preliminary results from a multicenter, European, prospective evaluation of the new, double flare, duodenal Evolution stent. Gastrointest Endosc. 2009;69(5):AB192-AB193.
Bloomington, IN – Cook Medical will present data supporting the submission for its Zilver® PTX® Drug-Eluting Stent in the superficial femoral artery (SFA) to the Food and Drug Administration’s (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee on October 13, 2011. Stanford University physician Michael Dake, M.D., the global principal investigator of Cook Medical’s Zilver PTX Drug-Eluting Stent clinical study, will present and highlight the data points.
“We’re excited to present the data on Cook Medical’s Zilver PTX Drug-Eluting Stent. The uncoated version of the Zilver self-expanding nitinol stent is approved and commercially available in the United States as a bare metal stent to treat lesions in the iliac arteries,” explained Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “We look forward to presenting this combination therapy device to the panel.”
WHAT:
FDA Panel will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the Zilver PTX Drug-Eluting Stent.
WHEN:
October 13, 2011
8:00 a.m. – 6:00 p.m. ET
WHERE:
Hilton Washington DC
620 Perry Pkwy
Gaithersburg, MD 20877
WHO:
Dr. Michael D. Dake, chief of interventional radiology at Stanford University Medical Center Dr. Gary Ansel, director, Center for Critical Limb Care, Riverside Methodist Hospital
Rob Lyles, vice president and global leader of the Peripheral Intervention division, Cook Medical
Ted Heise, Ph.D., vice president, regulatory scientific affairs, Cook Medical
Anthony Ragheb, PhD, vice president, MED Institute
April Lavender, senior vice president, global regulatory affairs, Cook Medical
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR
Bloomington, IN – Cook Medical will present data supporting the submission for its Zilver® PTX® Drug-Eluting Stent in the superficial femoral artery (SFA) to the Food and Drug Administration’s (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee on October 13, 2011. Stanford University physician Michael Dake, M.D., the global principal investigator of Cook Medical’s Zilver PTX Drug-Eluting Stent clinical study, will present and highlight the data points.
“We’re excited to present the data on Cook Medical’s Zilver PTX Drug-Eluting Stent. The uncoated version of the Zilver self-expanding nitinol stent is approved and commercially available in the United States as a bare metal stent to treat lesions in the iliac arteries,” explained Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “We look forward to presenting this combination therapy device to the panel.”
WHAT:
FDA Panel will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the Zilver PTX Drug-Eluting Stent.
WHEN:
October 13, 2011
8:00 a.m. – 6:00 p.m. ET
WHERE:
Hilton Washington DC
620 Perry Pkwy
Gaithersburg, MD 20877
WHO:
Dr. Michael D. Dake, chief of interventional radiology at Stanford University Medical Center Dr. Gary Ansel, director, Center for Critical Limb Care, Riverside Methodist Hospital
Rob Lyles, vice president and global leader of the Peripheral Intervention division, Cook Medical
Ted Heise, Ph.D., vice president, regulatory scientific affairs, Cook Medical
Anthony Ragheb, PhD, vice president, MED Institute
April Lavender, senior vice president, global regulatory affairs, Cook Medical
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR
Bloomington, Ind. – On the heels of President Obama’s speech to Congress about the critical need to accelerate US job growth, Cook Medical today applauded a new study from AdvaMed demonstrating that a new medical device excise tax would cost the US jobs, stifle innovation and limit patient access to new medical technologies.
The new tax, which goes into effect 2013, is in sharp contrast to the President’s job creation proposal. According to the AdvaMed study, the hefty 2.3 percent tax on medical device sales will negatively impact the operations of US-based medical device manufacturers and further exacerbate the decline of US manufacturing jobs. The report estimates that the excise tax will put about 43,000 – 10 percent – of the 400,000+ US-based medical device employees out of work, resulting in $3.5 billion in lost wages.
“Cook Medical has always been committed to improving the quality of patient care and working to ensure that patients have access to the latest medical device innovations. It is from this stance that the company approaches issues related to job creation, innovation and the medical device excise tax,” said Kem Hawkins, president of Cook Medical. “One of our main concerns from the AdvaMed report is that much of the current innovation in the US medical device industry could shift overseas. The US leads global innovation in medical devices. Stifling innovation could limit worldwide patient access to new medical technologies in the years to come. With the need to create and support US-based jobs, it is clear that Congress should repeal this tax based on the negative impact it will have on this critically important growth industry.”
Cook Medical remains committed to advancing the United States’ competitiveness in the global medical device marketplace through a focus on US-based jobs, and supports pending House and Senate legislation that would repeal the medical device excise tax, Hawkins added.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @CookMedicalPR.
Munich, Germany – Cook Medical, a world leader in minimally invasive medical technologies, has launched the world’s first-ever stent designed and approved specifically to treat symptomatic iliofemoral venous outflow obstruction. The Zilver Vena Venous Self-Expanding Stent has received CE Mark approval and is now available to physicians across Europe.
“We are proud to launch this important product at CIRSE 2011,” said Andy Förster, EMEA leader of Cook Medical’s Peripheral Intervention division. “This allows Cook Medical to offer physicians and their patients a good option to treat obstructive veins.”
Each year, one in 1000 people will experience venous thromboembolism (VTE) for the first time¹. More than 50 per cent of patients who develop nonfatal VTE will go on to develop post-thrombotic syndrome (symptoms such as skin discoloration, pain and swelling)². This post-thrombotic syndrome results from chronic scarring of the thrombosed veins, resulting in venous outflow obstruction and venous hypertension.
Based on Cook’s existing Zilver technology, Zilver Vena is designed to address many of the challenges of stenting diseased veins, which are very different from diseased arteries. Veins require a stent with strong radial force, good flexibility and large diameters.
Product features:
- Flexible, self-expanding stent made with ’shape memory’ nitinol
- No clinically significant stent foreshortening Available in 14 and 16 mm diameters and 60, 100 and 140 mm lengths to allow precise placement
- Provides consistently strong radial force from end to end
- Incorporates flexibility and kink-resistance of proven Zilver technology
- Compatible with 7 Fr sheaths and 9 Fr guiding catheters
- Deployed via 80 and 120 cm delivery systems
Dr Gerard O’Sullivan³, interventional radiologist at University College Hospital Galway, Ireland, comments:
“There is a significant lack of awareness of modern interventional techniques to remove thrombus and restore venous patency. Until now, physicians who recognise the benefits of venous stenting have been forced to adopt off-label use of stents designed for the arteries. This is challenging because, compared with arteries, veins have less muscle in the wall to keep them open and also have much higher elastic recoil, which tends to close them down unless you use a stent with high radial force.”
Förster comments: “Awareness of venous disease in Europe is increasing thanks to the efforts of governments, associations and industry. This will help more patients to be screened and diagnosed, but awareness of the treatment and prevention options remains low and stenting in the veins currently poses a number of questions for physicians about size and precision. We spent four years developing this product and hope that by taking the guesswork out of venous stenting with the launch of Zilver Vena, more physicians will adopt this type of procedure for treating venous obstruction.”
Förster adds, “Along with embolization products and IVC filters that we already have available for venous disease and prevention, we are developing a full suite of products for deep-vein recanalisation procedures, creating a full venous programme from Cook Medical.”
The Zilver Vena Venous Self-Expanding Stent is an investigational device not approved for sale in the United States.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit . Follow Cook Medical on Twitter @cookmedicalpr.
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¹ White RH. The epidemiology of venous thromboembolism. Circulation. 2003; 107(23)(suppl 1):I4-I8.
² Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism (VTE) in Europe: the number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;98(4):756-764.
³ Dr. O’Sullivan is a paid consultant to Cook Medical with respect to its medical devices.