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Medtronic Launches Endeavor® Sprint Drug-Eluting Stent System on Rapid Exchange in United States
MINNEAPOLIS – Nov. 12, 2008 - (HSMN NewsFeed) - Building on its reputation for excellence in the deliverability of its angioplasty products, Medtronic, Inc. (NYSE: MDT), announced today the U.S. market launch of the Endeavor Sprint drug-eluting stent (DES) on a rapid exchange (RX) delivery system.
Using the popular Sprinter™ balloon catheter technology, the Endeavor Sprint system puts the highly deliverable Endeavor DES on an enhanced delivery platform, making Medtronic’s flagship DES even easier for physicians to deliver to the site of coronary blockages. The Endeavor Sprint system incorporates a new tip design for a low profile, a new balloon material and an enhanced shaft design which together greatly improve the device’s deliverability.
“The Endeavor Sprint system takes deliverability to a new level,” said Prof. Ian Meredith of Monash Medical Centre in Australia. “It features a balloon catheter designed specifically for the stent it delivers. Combining it with RX, the Endeavor Sprint system further enhances the deliverability of the Endeavor DES, which already had high marks on this aspect of procedural success – even in challenging lesions.”
“Deliverability is important,” said Dr. Jeffrey Popma of Caritas Christi Health Care System in Boston, “but the Endeavor stent also offers the assurance of long-term safety and durable efficacy. It’s the combination of all three attributes that will make the Endeavor Sprint DES system such a welcome addition for physicians to use in treating patients with coronary artery disease.”
The robust ENDEAVOR clinical program has demonstrated that the Endeavor stent is associated with exceptionally low rates of stent thrombosis, myocardial infarction and cardiac death, as well as low and comparable rates of clinically-driven target lesion revascularization, out to as long as five years of patient follow-up. Representing various world geographies and patient subsets, the program has enrolled more than 10,000 subjects to date and will ultimately enroll more than 20,000 subjects in a combination of randomized controlled and single-arm clinical trials.
“The Endeavor Sprint drug-eluting stent system is the latest innovation to come out of our robust product pipeline in CardioVascular,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral Vascular business at Medtronic. “It represents the strong and ongoing commitment we have to the field of interventional cardiovascular therapeutics. That commitment will yield many more collaborative innovations in the future that fulfill the unmet medical needs of patients worldwide.”
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
NCCN Updates Guidelines for Colorectal Cancer
November 3, 2008 NCCN announces new updates to the NCCN Guidelines for Colon and Rectal Cancers. The updates include recommendations to the pre-treatment work-up and use of anti-cancer agents in patients with metastatic colorectal cancer depending on the status of the tumor’s KRAS gene. The changes are based on recent studies demonstrating that the tumor KRAS gene status is highly predictive of outcome with certain therapies.
FORT WASHINGTON, Pa.–(HSMN NewsFeed)–The National Comprehensive Cancer Network (NCCN) announces important updates to the NCCN Guidelines on Colon and Rectal Cancers. These changes reflect leading developments in the treatment of patients with colon and rectal cancers and represent the standard of care in oncology in both community and academic settings.
New to the NCCN Guidelines is the recommendation that a determination of the KRAS gene status of either the primary tumor or a site of metastasis should be part of the pre-treatment work-up for all patients diagnosed with metastatic colorectal cancer. Another important update to the NCCN Guidelines is that the epidermal growth factor receptor (EGFR) inhibitors, cetuximab (Erbitux®, Bristol-Myers Squibb Company/ImClone Systems Incorporated) and panitumumab (Vectibix®, Amgen), either as single agents, or, in the case of cetuximab, in combination with other agents, are now recommended only for patients with tumors characterized by the wild-type KRAS gene.
These modifications to the NCCN Colon and Rectal Cancer Guidelines are based on results of a number of recent studies demonstrating that the tumor KRAS gene status is highly predictive of outcome with anti-EGFR therapies. In these studies, statistically significant benefits of EGFR inhibitor therapy were restricted to patients with tumors characterized by the wild-type KRAS gene. Since anti-EGFR therapies were ineffective for patients with tumors characterized by known KRAS gene mutations, the NCCN panel concluded that the potential toxicity and expense of anti-EGFR therapies are not justified in this group of patients.
NCCN Clinical Practice Guidelines in Oncology™ are developed and updated through an evidence-based process with explicit review of the scientific evidence by multidisciplinary panels of expert physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at www.nccn.org.
About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.
The NCCN Member Institutions are: City of Hope, Los Angeles, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Comprehensive Cancer Center, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University, Columbus, OH; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute, Memphis, TN; Stanford Comprehensive Cancer Center, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The University of Texas M. D. Anderson Cancer Center, Houston, TX; and Vanderbilt-Ingram Cancer Center, Nashville, TN.
For more information on NCCN, please visit www.nccn.org.
Electronic Brachytherapy Accurately Delivers Non-Radioactive Therapy Directly to Breast and Endocavitary Cancer Sites
Research Studies and Initial Clinical Experience Presented at the AAPM Validate That Electronic Brachytherapy Consistently Delivers Radiation Therapy as Planned
HOUSTON, July 28 (HSMN NewsFeed) — The ability of Electronic Brachytherapy to accurately and consistently deliver localized, non-radioactive radiation treatment directly to cancer sites is the focus of a symposium and multiple research papers accepted for presentation at the 50th American Association of Physicists in Medicine Meeting, July 27 - 31 in Houston. According to Xoft, Inc., developer of the Axxent® Electronic Brachytherapy System, positive clinical results from initial breast cancer treatment experience has generated significant momentum for adoption of Electronic Brachytherapy (eBx). It has also spurred much research validating eBx use in additional applications, including the treatment of endometrial and endocavitary cancers.
In conjunction with the AAPM Meeting, Xoft is hosting a luncheon symposium, titled “Clinical and Regulatory Considerations for Electronic Brachytherapy.” Featuring a panel of leading physicists and radiation biology experts, the panel discussion will focus on breast cancer treatment experience to date, the impact of broader implementation of Electronic Brachytherapy on physicist workflow, dosimetry and treatment planning, and the regulation and control of the use of X-ray radiation sources.
“As one of the early clinical sites to treat breast cancer patients with Electronic Brachytherapy, we see this as a rapidly emerging treatment technique that not only competes well with existing HDR options, but has a number of distinct benefits,” said Salahuddin Ahmad, PhD, DABR, professor and director of Medical Physics, Department of Radiation Oncology, University of Oklahoma Health Sciences Center. “This includes supporting a shorter, five day treatment regimen without the use of a radioactive isotope, giving treatment centers the flexibility to perform treatment in minimally shielded rooms and offering patients a better experience since they no longer have to be isolated in a shielded room.
“We have been encouraged by our experience with the treatment of breast cancer and look forward to offering this technique as it expands to new applications, such as the treatment of endometrial cancer,” Dr. Ahmad added.
Separately, in the presented paper, “An Enabling Technology for Creating Sculpted Brachytherapy Dose Patterns with the Xoft Axxent® System,” one of more than 10 studies about Electronic Brachytherapy accepted for presentation, Xoft scientists studied the ability to partially attenuate X-rays from the Axxent system over controlled spatial areas, while minimizing changes to depth-dose characteristics. This would be the basis of an enabling technology to sculpt brachytherapy dose patterns to spare nearby critical structures, such as skin in breast brachytherapy treatments or bladder and rectum in gynecological brachytherapy. Results demonstrated that it is possible to create predictable, directed shadows in dose around the 50 kVp X-ray source. In a simulated breast treatment plan, using a simple model of the attenuation, isodose lines were shifted by several mm.
A series of studies compared the dose delivered by the Electronic Brachytherapy system in endocavitary applications to the dose predicted through treatment planning. In the study, “Dosimetry of an X-ray Endocavitary Proctoscope Adapted for use with the Axxent® Electronic Brachytherapy System,” researchers from Washington University in St Louis and Xoft analyzed the dose rate and uniformity at the aperture of an Electro-Surgical Instrument (ESI) Proctoscope when used with an Axxent X-ray Source. Measurements of dose rate and uniformity at the aperture of a 24 mm diameter ESI proctoscope indicate that the Axxent X-ray source may be a suitable alternative to the Philips RT-50 Endocavitary Unit for treatment of anal-rectal lesions.
The studies involving Electronic Brachytherapy are detailed in the following posters and oral presentations:
Measurement of Skin Dose When Using FlexiShield® with the Axxent® Electronic Brachytherapy System L. Kelley, S. Axelrod, A. Dutta, Xoft, Inc, Sunnyvale, Calif. Moderated Poster: Therapy - Brachytherapy; Session SU-DD-A2-3 Sunday, July 27, 1:30 pm; Exhibit Hall - Area 2
An Enabling Technology for Creating Sculpted Brachytherapy Dose Patterns with the Xoft Axxent® System S. Axelrod, D. Pettibone, Xoft Inc., Sunnyvale, Calif. Presentation: Brachytherapy 1; Session MO-D-AUD B3 Monday, July 28, 1:30 pm; Auditorium B
A High Precision, High Throughput Fixture for Routine Spatial Characterization of the Xoft Axxent® Miniature X-Ray Source L. Kelley, S. Axelrod, M. Powell, Xoft, Inc, Sunnyvale, Calif. Presentation: Measurements - Calibration and QA; Session TH-D-352-9 Thursday, July 31, 12:30 pm; Room 352
Film Based Treatment Plan Validation for a new Vaginal Applicator Using the Xoft Axxent® 50 KVp Miniature X-Ray Source S. Axelrod, L. Kelley, L. Mantese, T. Rusch, Xoft, Inc, Sunnyvale, Calif. Poster SU-GG-T-36
Dosimetry of an X-Ray Endocavitary Proctoscope Adapted for Use with the Axxent® Electronic Brachytherapy System® T. Rusch, E. Klein, L. Kelley, R. Myerson, S. Axelrod, Xoft, Inc. Sunnyvale, Calif. - Washington University, St. Louis, MO Poster SU-GG-T-36
X-ray transmission of vaginal cylinders for use with the Axxent® Electronic Brachytherapy System H. Hausen, L. Kelley, T. Lovoi, L. Mantese, T. Rusch, Xoft, Inc., Sunnyvale, Calif. Poster SU-GG-T-43
About Axxent Electronic Brachytherapy
The Axxent® Electronic Brachytherapy System has been developed to address a variety of oncological and non-oncological indications. The proprietary Axxent treatment platform is cleared for use in the treatment of cancers or conditions where radiation therapy is indicated. Specific applicators have been cleared for treatment of early stage breast cancer and endometrial and rectal indications. Designed to deliver electronic, X-ray- based radiation treatment, the Axxent System can be used in virtually any clinical setting under the supervision of a radiation oncologist. It is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Eliminating the need for heavily shielded environments, it gives radiation oncologists the flexibility to deliver therapy in a broader range of clinical settings without the complex handling and resource logistics necessary when performing brachytherapy using radioactive isotopes. As a result, tens of thousands of patients annually will have greater access to therapy that is delivered more easily and conveniently.
About Xoft, Inc.
Founded in 1998, Xoft develops leading-edge technologies for the practice of radiation oncology through Electronic Brachytherapy, which utilizes proprietary miniaturized X-ray tube technology. The Axxent® Electronic Brachytherapy System, Xoft’s first treatment system, is currently being used in Accelerated Partial breast irradiation (APBI) for the treatment of early- stage breast cancer and in the treatment of endometrial cancer. For more information, visit www.xoftinc.com
Axxent and FlexiShield are trademarks of Xoft, Inc.
The Molecular Profiling Institute Launches Mammostrat(TM) - A Novel, Molecular-Targeted, Prognostic Test for Breast Cancer Patients
PHOENIX, Sept. 5 (HSMN NewsFeed) — The Molecular Profiling Institute, Inc. (Molecular Profiling) announced today that they are now providing Mammostrat, a new molecular-targeted breast prognostic test, to breast cancer patients, nationwide. The Mammostrat prognostic test utilizes five immunohistochemical (IHC) biomarkers to classify patients into high-, moderate-, or low-risk categories for disease recurrence.
Robert Penny, M.D., Ph.D., the Chairman and CEO of the Molecular Profiling Institute stated, “Mammostrat will benefit the care of breast cancer patients nationwide by allowing their cancer to be quickly analyzed for prognosis by a direct light-microscopic evaluation of the cancer cells by a pathologist. This new test, which is performed on tissue preserved according to standard practice, streamlines the process for patients while providing the accuracy of direct visualization.”
The test was developed by Applied Genomics, Inc. who rigorously translated recent genomic insights in cancer into a novel immunohistochemistry test. Mammostrat test results have been validated using over a thousand patient samples in North America from clinics/organizations such as the Cleveland Clinic Foundation and the National Surgical Adjuvant Breast and Bowel Project — generating results with clear cut conclusions from multiple independent studies supporting the prognostic value of the test.
“We are excited to have partnered with the Molecular Profiling Institute, says Doug Ross, MD, PhD, Chief Scientific Officer of Applied Genomics. “Their expertise in advanced genomic and proteomic testing will provide a rigorous reference lab-based introduction of the test and broad reach in order to offer quality testing to patients nationwide.”
Because Mammostrat uses traditional immunohistochemistry technology, the test is expected to be significantly less expensive than existing molecular-based, prognostic tests for breast cancer and is typically covered by insurance. Todd Maney, Ph.D., Vice President of New Product Development, MPI, stated, “Mammostrat’s cost-effective, molecular-targeted analysis enables MPI to provide the test at a significant discount compared to our competitors. Moreover, test results will be available quickly — an average of seven business days — versus two weeks for alternative, comparable tests.”
Physicians may order the Mammostrat test direct from the Molecular Profiling Institute or through their distribution partner AmeriPath by visiting http://www.molecularprofiling.com.
About the Molecular Profiling Institute, Inc. — Molecular Profiling is a CLIA-certified specialty reference laboratory that helps patients, worldwide, by applying the discoveries of the Human Genome Project to personalized medicine. Molecular Profiling provides cutting-edge testing facilities, products, and resources for genomic and proteomic profiling and treatment of complex diseases, and pharmaceutical services to identify populations that may respond to targeted therapies. Molecular Profiling leverages strategic relationships with a number of organizations, including AmeriPath, Inc., the International Genomics Consortium (IGC), and the Translational Genomics Research Institute (tgen). Molecular Profiling’s Web site address is http://www.molecularprofiling.com.
About Applied Genomics — Applied Genomics, Inc. develops targeted diagnostics to improve treatment for cancer patients. Translating insights from genomic analyses of cancer, AGI creates antibody-based diagnostic tests for classifying cancer facilitating rational patient care decisions and improving quality of life for all patients. AGI has ongoing product development programs in breast, lung, ovarian, head and neck, and colon cancer. Additional company information is available at: http://www.applied-genomics.com.
Source: Molecular Profiling Institute
