Bloomington, Ind.—
Cook Medical is making its Hercules® 3 Stage Wire Guided Esophageal Balloon available to otolaryngologists to treat patients with gastrointestinal (GI) strictures. The device will be offered through Cook’s Otolaryngology-Head and Neck Surgery (OHNS) clinical division, while also continuing distribution directly to gastroenterologists through its Endoscopy clinical division.
GI strictures can interfere with eating, swallowing and digestion. They are treated endoscopically by passing a deflated balloon such as the Hercules into the strictured area, inflating the balloon to dilate the passage, and then deflating and removing the balloon. The balloon can also be used to open the lumen so that other procedures, such as biopsies or stent placement, can be performed.
The Hercules 3 Stage Wire Guided Balloon is available with a preloaded wire guide. The balloon is made with proprietary P.E.T. Flex™ technology, a material that combines tensile strength and flexibility. The Express Evacuation Catheter deflates the balloon when negative pressure is applied to the catheter with an inflation device.1 Even if clinicians begin the withdrawal process prior to complete deflation, Hercules can still be withdrawn through the scope.2
The Hercules balloon inflates to three distinct and increasing diameters, allowing the clinician to use a single dilator and reducing the need for multiple serial dilators. Two radiopaque markers on the body of the balloon enhance visualization to aid balloon positioning, and glow-in-the-dark labels and simplified packaging aid in product identification and procedural efficiency.
“Hercules esophageal dilation balloons are my go-to tools for the controlled dilation of the esophagus through flexible and rigid instrumentation,” says laryngologist, Paul Castellanos, MD, FCCP – Associate Professor of Surgery, Division of Otolaryngology Head and Neck Surgery, University of Alabama at Birmingham. “In my experience with this product, there was minimal to no obscuring of the stricture dilated.”
Available to doctors internationally, the Hercules 3-Stage Wire Guided Esophageal Balloon is the latest minimally invasive innovation Cook is introducing to ear, nose and throat physicians and the patients they treat. In addition to focusing on esophageal dilatation procedures, Cook Medical OHNS provides products that are used to treat salivary ductal disorders, as well as products used for soft tissue repair and ultrasound-guided biopsy.
Dr. Castellanos has a professional services agreement with 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 Twitter and LinkedIn.
1,2 Data on file at Cook Medical.
Bloomington, Ind., March 18, 2013 — Cook Medical has launched a suite of salivary duct access products that offer minimally invasive options for the treatment of obstructive salivary gland disease. Minimally invasive treatment of obstructive salivary gland disease can reduce the need for invasive open surgery.1
The devices in the product line include a soft-tip wire guide, a serial dilator set, the Kolenda Salivary Access Introducer Set and the NGage® and NCircle® salivary stone extractors. Physicians use these products in sialendoscopy, a minimally invasive procedure for visualizing and treating obstructive salivary gland disorders through the salivary ducts. Sialendoscopy can be performed in the physician’s office in an outpatient procedure and has been shown to reduce the risks of facial nerve paralysis and morbidity.2
The salivary duct access products are available to doctors internationally and are among the new minimally invasive devices that Cook Medical has launched as part of its new Otolaryngology—Head and Neck Surgery (OHNS) clinical division. Initially, Cook Medical OHNS will focus on products that are used to treat salivary gland disease, chronic sinusitis, vocal cord paralysis and obstructive sleep apnea, as well as products used for soft tissue repair and in interventional airway and esophageal procedures.
The most prevalent obstructive salivary gland disease is obstruction by salivary duct stones. Salivary duct stones account for approximately 50 percent of major salivary gland diseases.3 Obstruction by salivary duct stones is known as sialolithiasis and affects men (generally, middle-aged males) twice as often as women. If sialolithiasis is not treated, the obstructed area can become infected.4
Cook Medical’s new salivary duct access tools create a working channel through which physicians can treat obstructive salivary gland disease. The soft-tip wire guide is used to access the salivary duct through the duct opening and maintain ductal access throughout the procedure. Flexible serial dilators are introduced over the wire to expand the opening and prepare the salivary duct for the introduction of procedural instruments. The Kolenda introducer sheath is passed over the wire to create an open working channel into the salivary duct. The sheath serves to protect the ductal wall and allow for easy insertion and removal of the procedural instruments.
The stone extractors, including the NGage and the NCircle, have baskets that are made of nitinol “memory” wire, which allows the baskets to retain their shape following torsion. The baskets are used to manipulate and remove salivary stones.
About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving more than 40 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn. Follow Cook OHNS @cookohns.
1Kopec T, Witold S, Wierzbicka M. Sialoendoscopy and combined approach for the management of salivary gland stones [published online ahead of print August 9, 2012]. Eur Arch Otorhinolaryngol. doi:10.1007/s00405-012-2145-x.
2Al-Abri R, Marchai F. New era of endoscopic approach for sialolithiasis: sialendoscopy. Sultan Qaboos Univ Med J. 2010;10(3):382-387.
3Epker BN. Obstructive and inflammatory diseases of the major salivary glands. Oral Surg Oral Med Oral Pathol. 1972;33(1):2-27. Cited by: Capaccio P, Torretta S, Ottavian F, et al. Modern management of obstructive salivary diseases. Acta Otorhinolaryngol Ital. 2007:27(4):161-172.
4Kennedy K, Driscoll B. Salivary gland diseases. University of Texas Medical Branch at Galveston Web site. http://www.utmb.edu/otoref/grnds/sal2.htm. Published October 30, 1996. Accessed August 28, 2012.
Washington, D.C., Sept. 19, 2012 — As part of its commitment to advancing research in the field of otolaryngology/head and neck surgery (OHNS), Cook Medical with a strong history of philanthropy to encourage and support research and education, has supported the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Centralized Otolaryngology Research Efforts (CORE) Program.
Jeffrey B. Watson, M.D., University of California, San Diego (UCSD), was presented with the first Cook Medical/AAO-HNSF Resident Research Award for meritorious original resident research. The award, presented at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) conference in Washington, D.C. last week, is part of the CORE grants program, a collaboration of nearly 20 societies, foundations and sponsors focused on supporting OHNS research. The CORE program serves to facilitate recognizing and identifying research efforts that advance knowledge and treatments for head and neck disorders which affect millions of patients a year.
“Cook Medical saw that otolaryngologists need minimally invasive medical devices designed specifically for their practice. So last week, we launched our new Otolaryngology/Head and Neck Surgery clinical division. We’ve introduced new products for OHNS procedures, and broadened our support of research aimed specifically at advancing the work of otolaryngologists,” said Thomas Cherry, OHNS global clinical division leader for Cook Medical. “Now, we’re pleased to support, through the AAO-HNSF, medical residents who share our passion for developing new technologies and treatment options for head and neck disorders and diseases.”
Dr. Watson, a research scientist at UCSD, attended Harvard Medical School and has worked in various basic and clinical research settings both domestically and overseas. The grant will fund his research on tissue engineering technology, in which he is testing the ability of mechanical compaction of neocartilage constructs to develop sufficient septal cartilage for reconstructive surgery.
“We’re glad to welcome Cook Medical into the Centralized Otolaryngology Research Efforts grant program,” said Stephanie Jones, AAO-HNS director, Research and Quality Improvement. “Their support of a new-resident grant will help to expand our knowledge and understanding about paranasal sinus disease, salivary gland disease, sleep medicine, voice therapy, airway, ultrasound, tissue engineering, dysphagia and the cranial base.”
The CORE grant program provides financial support for research that may lead to new discoveries and treatments in otolaryngology-head and neck surgery. Its goal is to promote mentorship and teach young investigators to prepare competitive grant applications, and to prepare surgeon-scientists to serve as peer reviewers for the National Institutes of Health (NIH) and other research agencies. Since 1985, the AAO-HNSF has awarded close to 500 grants totaling nearly $8 million for research projects, research training and career development. Nearly a third of NIH grants held by otolaryngologists have been funded through CORE.
Cook unveiled its OHNS clinical division and the division’s inaugural interventional devices for obstructive salivary gland disease, dysphagia, dural repair following cranial base procedures and thyroid biopsy at the AAO-HNS conference last week.
Recognizing the need for specialized, minimally invasive devices in otolaryngology, Cook is researching and developing alternatives to open surgery for treating conditions across several traditional ear, nose and throat (ENT) specialties. Cook’s new OHNS clinical division leverages the interventional devices Cook helped pioneer in areas such as interventional radiology and urology, and applies them to the emerging science of minimally invasive otolaryngology and head and neck surgery. The division’s initial six practice areas of focus are soft tissue repair, salivary gland disease, chronic sinusitis, interventional airway procedures, vocal cord paralysis and obstructive sleep apnea.
About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving 41 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn.
About the AAO-HNS
The American Academy of Otolaryngology – Head and Neck Surgery (www.entnet.org), one of the oldest medical associations in the nation, represents more than 11,000 physicians and allied health professionals who specialize in the diagnosis and treatment of disorders of the ears, nose, throat and related structures of the head and neck. The Academy serves its members by facilitating the advancement of the science and art of medicine related to otolaryngology and by representing the specialty in governmental and socioeconomic issues. The organization’s vision: “Empowering otolaryngologist-head and neck surgeons to deliver the best patient care.”
Washington, D.C. — Cook Medical, a world leader in minimally invasive medical device technology, has launched its new Otolaryngology/Head and Neck Surgery (OHNS) clinical division to bring the benefits of the company’s devices for non-surgical procedures to a new group of physicians and the patients they treat.
Recognizing the need for specialized minimally invasive devices in otolaryngology, Cook OHNS is researching and developing alternatives to open surgery for treating conditions across several traditional ear, nose and throat (ENT) specialties.
Cook officially unveiled the new clinical division and a selection of its current and upcoming products —salivary duct access tools, stone extractor set, Biodesign® dural advanced tissue graft, Hercules® 3 Stage Wire Guided Balloon and the Chiba EchoTip® Biopsy Needle—at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) conference in Washington, D.C., this week.
The division’s initial six practice areas of focus are soft tissue repair, salivary gland disease, chronic sinusitis, vocal cord paralysis, obstructive sleep apnea, and interventional airway and esophageal procedures. There is great potential within these six areas to bring new treatment options, many of which are alternatives to open surgery, to millions of patients in the U.S. and globally, Cook officials said.
“We started Cook OHNS to pioneer ways to provide patients with diseases affecting the head and neck with less traumatic alternatives to surgeries. As we met with physicians, we heard loud and clear that they saw many opportunities for minimally invasive medical devices in this field,” said Thomas Cherry, global leader for Cook Medical’s OHNS division. “At our core, we’ve always solved problems for clinicians over Cook’s entire history. So now, Cook OHNS is taking proven interventional tools and techniques and applying them to the emerging science of minimally invasive otolaryngology and head and neck surgery.”
Cook will showcase the following products at AAO-HNS:
Salivary Duct Access Products: Intended to reduce trauma for the patient and reduce the need for open surgery, the tools in this product line help physicians perform minimally invasive sialendoscopy procedures. The devices, which include a wire guide, dilator set, Kolenda introducer sheath and the NGage® and NCircle® salivary stone extractors, help enable physicians to gain access to stones and remove them in the physician’s office without surgery.
Hercules 3 Stage Esophageal Balloon: The Hercules 3 Stage Esophageal Balloon is designed to treat abnormal narrowing of the digestive tract that can interfere with eating, swallowing and digestion. The device is made with proprietary P.E.T. Flex™ technology, a material that optimally combines the high tensile strength and flexibility necessary for a strong balloon that inflates to three distinct and increasing diameters.
Chiba EchoTip Biopsy Needle: The high-visibility EchoTip biopsy needle allows physicians to perform thyroid biopsy with a needle that can be easily seen under ultrasound. High visibility results in more accurate needle placement and reduces the number of needle passes needed to obtain a sufficient sample. The Chiba EchoTip biopsy needle design provides enhanced visualization of needle tip when used with ultrasonic imaging equipment to ensure a strong, hyperechoic reflection and clearly visible images.
“There is a definite need for true out-of-the-box thinking around minimally invasive medical technology for OHNS,” said Patrick Melder, M.D., of ENT Associates of North Georgia and a presenter at the AAO-HNS conference. “Cook Medical has a solid and lengthy track record in innovating minimally invasive technologies, and has the ability to help transform the way we may approach such things as reducing post-tonsillectomy pain or advancing our understanding of the treatment of sinusitis.”
“For months, Thomas Cherry kept saying we could help a large group of patients if we could make our products available to them, and he was right. He was doing what Cook has always done; listened to physicians, heard what they needed and given them the tools to treat patients in a better way,” explained Pete Yonkman, executive vice president of strategic business units for Cook Medical.
OHNS is Cook’s 10th active clinical division. The company currently operates Aortic Intervention, Critical Care, Endoscopy, Interventional Radiology, Lead Management, Peripheral Intervention, Surgery, Urology and Women’s Health divisions as well. Dr. Melder is a paid consultant to Cook Medical with respect to its medical devices.
About Cook Medical
A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts and cell therapies across more than 16,000 products serving 41 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter and LinkedIn.