Cook Medical Applauds AdvaMed Report That Medical Device Excise Tax Would Cost US 43,000 Jobs, Stifle Innovation and Limit Patient Access…

Bloomington, Ind. – Today, the Bloomington Chamber of Commerce announced Cook Group as the 2016 Workforce Development Award recipient in recognition the My Cook Pathway program the company launched in June. In partnership with Monroe County Community Schools Adult Education at Broadview Learning Center and Ivy Tech Community College Bloomington, the program creates a pathway between education and jobs in the community.

“Since our announcement this summer, more than 250 people have signed up to further their education,” said Pete Yonkman, president of Cook Medical and Cook Group. “We’re honored to be recognized with this award because it’s a proof point to the impact that meaningful partnerships can make in communities like Bloomington.”

Part of the redesigned education program includes a collaboration with Ivy Tech Bloomington called Achieve Your Degree. At no cost to the employee, this program allows participants to earn a certificate in seven programs including biotechnology, business administration, hospitality and various computing and informatics tracks. They can also continue their education by earning an Associate degree in these curricula developed for Cook.

Cook also developed a program with Broadview Learning Center for employees to work part-time while they pursue their High School Equivalency (HSE). Individuals in Southwest Central Indiana interested in working at Cook who do not have a high school diploma or HSE are eligible to participate in the program after successfully completing the pre-employment screening process. After attending the free seven-week preparatory class then taking and passing the Test Assessing Secondary Completion to obtain their HSE, individuals are eligible for a full-time position at Cook.

“From tuition assistance and the Achieve Your Degree program at Ivy Tech to individuals earning their High School Equivalency, the positive feedback about My Cook Pathway has been phenomenal,” said Katie Smith, director of Human Resources at Cook Medical. “We’re seeing the first round of students working to achieve higher education and it’s already clear that this program will change lives in our community.”

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn.

Las Vegas, Nev., November 4, 2014 — Five-year results from the largest and longest-running clinical trial of a drug-eluting stent for treating peripheral arterial disease (PAD) confirmed long-term patency for patients treated with Zilver PTX.

The results were presented today by Michael Dake, M.D., of Stanford University, at the 2014 Vascular Interventional Advances (VIVA) meeting.

Data from the Zilver® PTX® Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease showed 5-year primary patency of 66.4 percent in the superficial femoral artery (SFA) for patients treated with Cook’s paclitaxel-eluting stent. This compares to 43.4 percent patency for patients with balloon angioplasty or provisional bare metal stent placement.¹

“At five years, Zilver PTX demonstrated a 48 percent reduction in reintervention and a 41 percent reduction in restenosis compared to standard care,” Dr. Dake told the VIVA audience. “Five-year data for Zilver PTX versus bare metal stenting confirm a sustained benefit for the paclitaxel-eluting stent. Zilver PTX continues to show benefit through five years with no late catch-up.”

“Cook’s commitment to providing clinical evidence of the effectiveness of drug-eluting devices in the peripheral vessels is unmatched. With this new data showing durable patency at five years, we’re confident our Zilver PTX stent offers PAD patients a lasting benefit,” said Mark Breedlove, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division.

The Zilver PTX Randomized Trial of Paclitaxel-Eluting Stents for Femoropoliteal Artery Disease was a 479-patient multicenter, prospective, randomized study. It was designed to evaluate the PTX stent as a treatment for peripheral arterial disease (PAD) in the superficial femoral artery (SFA).

Dr. Dake, a global principal investigator for the Zilver PTX trial, is a paid consultant to Cook Medical regarding the research and development of medical devices.

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery.  Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently.  We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter and LinkedIn.

Use and potential contraindications: The Zilver PTX Drug Eluting Stent is intended for treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel size from 4 mm to 7 mm and total lesion lengths of up to 140 mm per limb or 280 mm per patient.  The use of this drug-eluting peripheral stent carries the risks associated with peripheral artery stenting including vascular complications, and/or bleeding events.

1. Dake M. The Zilver PTX randomized trial of treating femoropopliteal artery disease: 5-year results. Presented at: Vascular Interventional Advances (VIVA); November 4-7, 2014; Las Vegas, NV.

Bloomington, Ind. – In an effort to provide surgeons and nurses with an advanced tool to better monitor blood flow during free flap procedures, Cook Medical has launched the Doppler DP-M350 Blood Flow Monitor, a medical device at the forefront of transplant and reconstructive surgery.

“Cook’s Doppler DP-M350 Blood Flow Monitor has the ability to detect changes in blood flow immediately following transplant and reconstructive surgeries so a surgeon can intervene before free flap failure,” said Andy Cron, vice president of Cook Medical’s Surgery business unit. “We are proud to offer surgeons this latest enhancement to the Doppler system, and look forward to working with some of the world’s leading medical institutions to help improve overall patient care.”

With flow indication lights and audio confirmation, Cook’s Doppler system allows surgeons to continuously monitor for loss of patency or thrombosis.

“The ability to identify a blood flow problem quickly is important because there is a short critical window of time during which the surgeon can salvage a struggling free tissue transfer,” said Dr. Michael Gimbel, an assistant professor of surgery at the University of Pittsburgh. “Cook’s Doppler system has the unique ability to monitor difficult-to-reach vascular areas and detect a stop in blood flow so a surgeon can intervene before it’s too late. Additionally, the Cook system aids in flap insetting, as it can help detect a vessel kink prior to leaving the OR.”

The Doppler DP-M350 Blood Flow Monitor received U.S. Food and Drug Administration clearance in March 2011.

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 biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter and LinkedIn.

Dr. Michael Gimbel has no financial relationship with Cook Medical.

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.