Bloomington, Ind., September 24, 2014 – Connie Jackson, who has served as global vice president of human resources since 2005, has been promoted to senior vice president of human resources, the company said today. As senior vice president, Jackson will continue her responsibility for human resources globally for Cook Group Incorporated and its affiliates.
“Connie has been a leader within the Cook organization for more than 36 years, ” said Pete Yonkman, president of Cook Medical. “Over the years, we’ve asked Connie to move from a local HR manager to a global leader within the company. She has met and exceeded this challenge while establishing best practices in human resources across the Cook organization.”
Jackson is a true success story that is not uncommon at Cook. She joined the company in 1978 as a receptionist and eventually took on the role of supervisor for the payroll and insurance departments. In 1988, she assumed the role of personnel advisor and in 1996 she began work as manager of the human resources department. Jackson was named vice president of human resources for Cook Incorporated in 2005. During her tenure at Cook, Jackson has worked tirelessly to advocate for employee benefits, conduct interviews nationwide to support Cook’s expanding workforce, coordinate data compilation required for the US Department of Labor, and support work on personnel issues for Cook companies globally including the French Lick Resort. Jackson lives in Bloomington, Ind., with her husband and enjoys spending time with her two sons and one grandson.
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.
Bloomington, Ind., September 24, 2014 – Cook Medical is pleased to announce that Jean-Marc Creissel has been named vice president of the Urology clinical division. He has served as global leader of the business unit since 2010. As vice president, Creissel will continue his global responsibility for sales and marketing, product development, financial performance and general management of the Urology division. Cook’s Urology products span a wide range of procedures, and help treat a variety of diseases ranging from kidney stones to prostatic hyperplasia.
“Jean-Marc has done a fantastic job leading our Urology team for the past four years,” said Pete Yonkman, president of Cook Medical.
“Under his leadership, the division has experienced steady growth every year and launched a number of innovative products. His focused passion for being a stone management solution partner for physicians led to the first stone extraction cases done completely, start to finish, using just Cook products earlier this year.”
Creissel joined Cook as a sales representative in Paris in 1990. Since then, he has served in a variety of sales and product management roles, including sales and marketing manager for Europe, the Middle East, and Africa, and global director of product management. His 24 years of experience in urology devices has led to an extensive understanding of the issues that urological health faces, both clinical and administrative. Evidence of this understanding can be seen in the clinical solutions that his team has developed, but also in their efforts to develop products that help reduce operating time and prevent the need for repetitive treatment, to lift some of the administrative burden that comes naturally as patient populations grow.
Creissel moved to the U.S. in 2008 and currently resides in Bloomington, Ind. He received his State Doctorate in Pharmacy from the Universite Rene Descartes in Paris.
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.
For Immediate Release: August 26, 2014
Cook Medical
750 Daniels Way
Bloomington, IN 47404
www.cookmedical.com
Telephone Number: 812-339-2235
On July 10, 2014, Cook Medical initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare.
Customers have been advised to return the recalled devices to Cook Medical. The recall affects products manufactured between August 2012 and August 2013 and distributed between March 8, 2013, and July 1, 2014.
The following product has been recalled:
Model: CloverSnare™ 4-Loop Vascular Retrieval Snare
Model Number: VRS-6.0-9.0
Lot Numbers: 3583416; 3583418; 3583422; 3583424; 3583426; 3583428; 3583430; 3583432; 3583434; 3583436; 3583440; 3583442; 3583452; 3583456; 3583458; 3583462; 3583464; 3583466; 3583468; 3583470; 3583472; 3583474; 3583476; 3583478; 3583480; 3583482; 3583484; 3583486; 3583488; 3583490; 3583492; 3583494; 3583496; 3583498; 3583500; 3583502; 3583504; 4293921; 4293923; 4293925; 4293927; 4319573; 4319575; 4319577; 4319579; 4319581; 4319583; 4319585; 4319587; 4319589; 4319591; 4572365; 3583418X; 3583430X; 3583442X; 3583442XX; 3583464XXX; 3583480XX; 3583486X
Quantity: 696
In six cases, customers reported separation of the loop snare from the shaft during use. The separation was caused by the application of lateral force to the snare in an effort to change the shape of the device. In four cases of separation, medical intervention to retrieve the separated snare was required.
Cook Medical has notified all customers of the recall by letter and has arranged for affected devices to be returned. In addition, Cook Medical has notified the FDA of this action. The recall affects customers in the United States, Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden and Switzerland. Cook reports that the problem occurred only in these specific lots. There have been no known problems in the devices manufactured after that time.
Customers with questions may contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235 Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or by email at CustomerrelationsNA@cookmedical.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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.
Vandergrift, Pa. — Effective immediately, Cook Medical customers in the United States will again have access to its Evolution® RL and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Sets. Distribution of these products within the U.S. market was suspended for two months while Cook’s Lead Management clinical division worked with the U.S. Food and Drug Administration (FDA) to resolve agency questions about the marketing clearance of these products. The devices, which remained available in Europe and other markets, were not recalled by FDA.
“For a quarter century, Cook has been at the forefront of cardiac lead extraction technology. Our latest devices in the Evolution RL line offer physicians the ability to control either uni-directional or bi-directional operation for mechanical extraction of problematic pacemaker and ICD leads and indwelling catheters,” said Louis Goode, vice president and global leader of Cook Medical’s Lead Extraction division. “We’re very pleased to be able to again provide these devices to U.S. physicians.”
Both the Evolution RL and Evolution Shortie RL, he added, are indicated for use in cardiac rhythm management patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. See instructions for use.
Earlier this year, the Lead Management division launched an educational website on Cook’s role in supporting the development of the mechanical lead extraction procedure and the devices needed to perform these operations.
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.
Bloomington, Ind., — Cook Medical is engaged in two clinical studies that will provide additional data on the safety and effectiveness of inferior vena cava (IVC) filters.
The first study, the Cook Inferior Vena Cava Filter (CIVC) study, will add to Cook’s existing clinical data on its commercially available IVC filters. This includes three previous studies including more than 1,300 patients treated with Cook IVC filters. CIVC will also address filter safety concerns expressed in the 2010 and 2014 safety communications from the U.S. Food and Drug Administration (FDA). The study’s primary endpoints will be technical placement success and one-year freedom from new symptomatic pulmonary embolism, and one-year freedom from major adverse events.
CIVC will collect additional safety and effectiveness data on Cook’s permanent and retrievable filters. Enrollment in the CIVC study began in March 2014. Up to 470 patients at up to 40 international sites will be enrolled in the study.
The second study, the PRESERVE study, will involve collaboration between Cook, the Society for Vascular Surgery, the Society of Interventional Radiology, the FDA, and other filter manufacturers, and will enroll patients in the US only.
“Cook believes in providing physicians the data they need to make the best decisions possible when treating patients. In this case, these two studies should go a long way toward adding to the medical science on IVC filters,” said Mark Breedlove, vice president and global business unit leader for Cook Medical’s Peripheral Intervention clinical division.
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.
Orlando, Fla. – Cook Medical will exhibit augmented reality experiences, which is a technology used to simulate use of products, and host a skills challenge at their booth, #1617, at the annual American Urological Association (AUA) meeting. The booth will highlight Cook’s commitment to education and innovation.
“Education has been and will continue to be a crucial component of the support we give our customers,” said Jean-Marc Creissel, global leader of Cook Medical’s Urology division. “This year at AUA, we are excited to be delivering our instructive efforts through fun and more creative channels in a non-clinical setting. AUA is a proven partner in our global educational efforts and we are looking forward to another productive show.”
WHEN:
Augmented Reality Experiences
Saturday, May 17: 10 a.m. – 5:30 p.m.
Sunday, May 18 – Monday, May 19: 9 a.m. – 4 p.m.
Tuesday, May 20: 9 a.m. – 3:30 p.m.
Skills Challenge – Exhibit hall hours
Saturday, May 17: 10 a.m. – Tuesday, May 20 at 12 p.m.
WHERE:
S & T Hall: Booth #1617
Orange County Convention Center
Orlando, Fla.
WHAT:
Augmented Reality Experiences
All visitors are invited to learn more about Cook Medical’s Urology products by participating in augmented reality experiences. The experiences demonstrate the capabilities of innovative products, including:
•NGage® Nitinol Stone Extractor: Highlights the ability to reposition and release stones or remove a stone
•Rhapsody H-30™ Holmium Laser System: Showcases the difference between the long and short pulse width, and shows how pulse width affects stone movement and how the stone breaks
•BIGopsy® Backloading Biopsy Forceps: Highlights the sample size that can be obtained when BIGopsy is used
•Resonance® Metallic Ureteral Stent: Demonstrates the pressure that the stent can withhold when compressed by a tumor
Skills Challenge
Participants will have one minute to use the PERC NGage®, PERC NCompass®, or PERC NCircle® to remove as much stone burden as possible. Participants will then choose from the nitinol ureteroscopy baskets and be given two minutes to attempt to remove the burden ureteroscopically. The winner will be chosen on the basis of the total combined weight removed and will be announced by AUA officials at 12 p.m. on May 20 in the Residents Bowl area.
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.
San Francisco, Calif. — A quarter century ago, doctors treating patients with implanted cardiac pacemakers had a big problem. Their patients were outliving the complex electrical devices that gave them an acceptable quality of life.
Pacemaker lead wires that deliver electricity to the heart broke, effectively stopping the pacemaker from functioning. Old leads could harbor sometimes-fatal infections that were difficult to treat if the lead was left in place. And because these were such sick patients to begin with, no one had anticipated the need to extract faulty leads years or even decades later. After only a year or two, leads can become trapped in place by scar tissue and increasing amounts of calcium build-up, making extraction challenging.
Medicine had no standard tools or techniques for the procedure then. One pioneer in the field says removing a bad lead back then was “a dark art.”
But by the mid-1980s, physicians, in cooperation with industry, began developing specialized mechanical lead extraction tools such as the locking stylet and the telescoping sheath to improve the procedure. They honed in on standardized extraction techniques. Working with Cook Medical, they pioneered a new medical procedure – cardiac lead extraction. This year marks the 25th anniversary of the first commercially available mechanical lead extraction devices.
As more pacemakers and defibrillators are implanted each year, the need for lead removal continues to grow. Currently, there are more than seven million cardiac devices implanted in patents worldwide. Each year another one million patients receive a pacemaker or defibrillator. Patients are receiving implants at younger ages, increasing the length of time these devices are implanted. In the next year alone, 10-15,000 cardiac leads will require extraction.
Drs. Charles Byrd, Charles Love, Ray Schaerf and Bruce Wilkoff and Cook Medical’s Lou Goode were among the first to see the need.
“This was a time when a band of physicians was working to fix a very serious medical problem, and they came to us for help,” said Goode, now global leader of Cook Medical’s Lead Extraction clinical division. “And by working together, we created a standardized set of tools to extract leads more safely, and the clinical procedure to use those devices.”
“We have such better tools now,” said Dr. Wilkoff. “In the beginning, before standardized devices or techniques, every procedure was an adventure.”
To help educate physicians and patients on the history of this medical innovation, Cook has created an educational website commemorating the anniversary. For more information about the 25th anniversary of lead extraction and the history of the procedure, please visit Lead Extraction at 25.
“Pacemaker technology will continue to change and so will the procedure. In the future, more and more devices will be implanted. Someone will need to figure out how to retrieve these devices, and we’re up to the challenge,” said Goode.
Dr. Charles Byrd is a paid consultant to Cook Medical with respect to its 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 Facebook, Twitter and LinkedIn.
Chicago, Ill. – This week is Digestive Disease Week (DDW), and at the world’s largest gathering of physicians and researchers in the gastroenterology field, nine abstracts and other clinical data will be presented on Cook Medical products. Cook’s line of EchoTip® ProCore™ High Definition Ultrasound Biopsy needles are featured in many of these presentations, including two randomized controlled trials by Drs. Masayuki Kitano and Srinadh Komanduri. There is also an economic analysis by Drs. Sachin Wani, Srinadh Komanduri and Ananya Das included in the presentations.
Dr. Kitano of Kinki University, Osaka-Sayama, Japan conducted a trial across nine Japanese centers and included 214 patients. The trial aimed to compare the availability of histological diagnosis between the EchoTip ProCore with a core trap and the standard 25 gauge EchoTip Ultra. “This prospective multicenter randomized controlled trial indicated that the 25G ProCore needle with a single pass offers significantly better sample quality for histological diagnosis of solid pancreatic tumors compared with the 25G standard needle,” said Dr. Kitano in the trial’s conclusion.
Drs. Wani of the University of Colorado, Komanduri of Northwestern University, and Das of the Arizona Center for Digestive Health, performed an economic analysis that compared two strategies in patients undergoing endoscopic ultrasound-guided tissue sampling. The two strategies compared included endoscopic ultrasound fine needle aspiration (EUS-FNA) with an on site cytopathologist, and endoscopic ultrasound fine needle biopsy (EUS-FNB) without an on site cytopathologist. This included two passes, and specimens were then submitted to pathology for histologic evaluation. Through this cohort, Drs. Wani, Komanduri and Das showed that EUS-FNB was more cost-effective than EUS-FNA for pancreatic and non-pancreatic masses. These results were confirmed in a sensitivity analysis (Monte Carlo analysis) that included a hypothetical cohort of 1000 patients undergoing EUS-guided tissue sampling comparing EUS-FNA with EUS-FNB. “This cost-analysis suggests that EUS-FNB of pancreatic and non-pancreatic masses may be a more cost-effective strategy than EUS-FNA,” said Wani in the analysis’ conclusion.
The primary aim of Dr. Komanduri’s study, which included 128 patients from six centers in the United States, was to compare the overall diagnostic yield of malignancy of EUS-FNA to EUS-FNB using a crossover design. “Results of this multicenter randomized controlled trial demonstrate superior diagnostic yield and specimen adequacy for non-pancreatic mass lesions sampled by EUS-FNB,” said Komanduri in the trial’s conclusion.
“These annual physician meetings are the best forum for sharing the latest discoveries in patient care,” said Barry Slowey, global leader of Cook Medical’s Endoscopy division. “We believe that the ProCore technology has huge implications for diagnosing patients, so it’s exciting to see our products featuring in many of these discussions.”
Saturday, May 3
•Prospective Multicenter Randomized Controlled Trial of Histological Diagnostic Yield Comparing 25G EUS-FNA Needles with and Without a Core Trap in Patients with Solid Pancreatic Masses
oPresented at S505 Topic Forum, 10:00 a.m. – 11:30 a.m.
•Biomarker Assessment From EUS Guided Biopsy Predicts Survival Outcomes and Surgical Treatment in Pancreatic Carcinoma
oPresented at South Hall Poster Session, 8:00 a.m. – 5:00 p.m.
Monday, May 5
•EUS-FNA of Solid Pancreatic Lesions: a Prospective, Randomized, Single Blinded, Comparative Study Using the 22-Gauge EchoTip® ProCore™ HD and the 22-Gauge EchoTip® Ultra HD Endoscopic Ultrasound Needles
oPresented at ASGE Poster Sessions, 8:00 a.m. – 5:00 p.m.
•EUS-Guided Fine Needle Biopsy for Histopathologic Evaluation of Solid Liver Masses
oPresented at ASGE South Hall Poster Sessions, 8:00 a.m. – 5:00 p.m.
•Comparison of Capillary vs Aspiration Technique in Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA): a Preliminary Report
oPresented at ASGE Poster Session, 8:00 a.m. – 5:00 p.m.
Tuesday, May 6
•Fine Needle Biopsy (FNB) is More Cost-Effective Than Fine Needle Aspiration (FNA) for Endoscopic Ultrasound Guided Tissue Sampling: an Economic Analysis
oPresented at S505 Topic Forum, 2:00 p.m. – 3:30 p.m.
•A Multicenter Prospective Randomized Controlled Cross-Over Trial Comparing Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) for Pancreatic and Non-Pancreatic Masses
oPresented at S505 Topic Forum, 2:00 p.m. – 3:30 p.m.
Cook Medical will be showing the EchoTip ProCore at their booth, #2538, along with products in hemostasis, stenting and biliary. Cook is also offering hands-on training in the booth.
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.
Dr. Komanduri is a paid consultant for Cook Medical.