Monday, April 28, 2008
Device Designed to Lower High Blood Pressure May Offer Hope
New Implantable Device Designed to Lower High Blood Pressure May Offer Hope for Millions of Patients
Early Hypertension Clinical Trial Results Show Significant Reduction in High Blood Pressure
May - Hypertension Awareness Month - Recognizes High Blood Pressure as a Top Risk Factor for Stroke, Heart and Kidney Disease
-- April 28, 2008 --CVRx:
WHAT: May is Hypertension Awareness Month, and a new device for high blood pressure now in clinical trials is showing promise for treating U.S. hypertension (high blood pressure) patients whose condition is not controlled by drugs. Rheos® Hypertension (HT) Therapy is the only implantable device designed to lower high blood pressure. It uses the body's natural blood pressure sensor (the baroreflex) to reduce blood pressure. Early hypertension clinical trial results showed a 39 mmHg reduction in systolic blood pressure at one year of use. High blood pressure is the number one risk factor for stroke, heart and kidney disease.
The Rheos HT Therapy is designed to electrically activate the carotid baroreceptors, the body's natural pressure sensors. When the baroreceptors are activated, signals are sent through the neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to various parts of the body-including the blood vessels, heart and kidneys. The Rheos HT System was developed by Minneapolis-based CVRx, Inc. (www.cvrx.com). The Rheos pivotal trial is currently under way. To learn more about the trial, patients can call 1-(888) 8BP-RISK (1-888-827-7475) or visit www.bloodpressuretrial.com.
WHY: Hypertension affects approximately 73 million people in the United States alone. High blood pressure is the number one risk factor for stroke and causes an estimated one in eight deaths worldwide. Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes.
According to the National Institutes of Health, approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications. These patients may not respond to drugs, or they may not be able to maintain their complex medication regimens. Early Rheos HT clinical results have shown the device has the potential to significantly reduce blood pressure in patients who cannot control their blood pressure with medications. One-year results from 13 patients showed a 39 mmHg average decrease in systolic blood pressure and a 26 mmHg average decrease in diastolic blood pressure.
HYPERTENSION STROKE FACTS:
May is Hypertension Awareness Month, sponsored by the U.S. Department of Health and Human Services. In the United States:
* High blood pressure is the number one stroke risk factor and accounts for an estimated 70 percent of all strokes. It is also one of the most important controllable risk factors for stroke prevention.
* Stroke is the number three cause of death.
* Twice as many women die from stroke each year than from breast cancer.
* Approximately 750,000 Americans suffer a stroke each year and 80 percent of strokes are considered preventable, according to the National Stroke Association.
INTERVIEW OPPORTUNITIES:
* Rheos study physicians
* Nadim Yared, president and CEO of CVRx
ADDITIONAL EVENTS DURING HYPERTENSION AWARENESS MONTH:
* May 4: ISHIB Worship Site Health Education Program (WSHEP)
* May 17: World Hypertension Day
CVRx BACKGROUND AND MEDIA KIT: CVRx is a private company founded in 2001 and headquartered in Minneapolis. For more information and a media kit, visit www.cvrx.com.
* CAUTION: The CVRx Rheos System is an investigational device and is limited by Federal law to investigational use only.
CVRx, Rheos, Baroreflex Activation Therapy, and BAT are registered trademarks of CVRx, Inc. © CVRx, Inc. 2008.
Contacts
CVRx
John Brintnall, 763-416-2853
Chief Financial Officer
jbrintnall@cvrx.com
Mary McGrory-Usset, 651-308-8225
Corporate Communications
mmcgroryusset@comcast.net
or
Padilla Speer Beardsley
Nancy Johnson, 612-455-1745
njohnson@psbpr.com
Nick Banovetz, 612-455-1705
nbanovetz@psbpr.com
Wednesday, April 23, 2008
Findings Reported at Cancer Conference Say Survival and Longer Term Disease Control Important
Findings from a multi-center clinical trial sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) demonstrated that lowering the dose of the steroid dexamethasone when paired with REVLIMID® to treat newly diagnosed myeloma, not only reduces side effects, but also improves long-term survival. The data are being discussed and evaluated at the 49th annual meeting of the American Society of Hematology (ASH) in Atlanta. According to the Mayo Clinic Cancer Center, lead institution for the study, the data show a "distinct survival benefit" with lower doses of the dexamethasone combined with REVLIMID. S. Vincent Rajkumar, M.D., hematologist and lead investigator of the study at the Mayo Clinic added, "This is a major advance in the treatment of cancer, and also gives researchers a new direction to explore - that more is not necessarily better when it comes to fighting the cancer."
North Hollywood, CA, and Atlanta, GA - December 14 -- The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said new data being reported at a global cancer conference require a new approach to evaluating cancer treatments. Findings from a multi-center clinical trial sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) demonstrated that lowering the dose of the steroid dexamethasone when paired with REVLIMID® to treat newly diagnosed myeloma, not only reduces side effects, but also improves long-term survival. The data are being discussed and evaluated at the 49th annual meeting of the American Society of Hematology (ASH) in Atlanta.
According to the Mayo Clinic Cancer Center, lead institution for the study, the data show a "distinct survival benefit" with lower doses of the dexamethasone combined with REVLIMID. S. Vincent Rajkumar, M.D., hematologist and lead investigator of the study at the Mayo Clinic added, "This is a major advance in the treatment of cancer, and also gives researchers a new direction to explore - that more is not necessarily better when it comes to fighting the cancer."
The data showed REVLIMID, an oral medication from Celgene, plus low-dose dexamethasone improves one year survival compared to the standard high-dose dexamethasone, 96% to 88%. Over two years the benefit continues with an 87% survival rate for low-dose dexamethasone compared to a 75% survival rate for high-dose dexamethasone. While lowering the dose of the steroid also lowers some immediate measures of response that is offset by better, long-term disease control.
"Lowering the doses of the steroid dexamethasone with REVLIMID gives us a new paradigm of treatment," said Brian G.M. Durie, M.D., chairman and co-founder of the International Myeloma Foundation. "When we combine REVLIMID with lower dose dexamethasone, we are seeing reduced side effects so patients stay on the drug longer, and, above all, significant survival benefits. These are the outcomes that patients and physicians find most important, and take precedence over the traditional ways we have used to evaluate new therapies."
Last April the independent committee monitoring the trial found the preliminary results so compelling that the trial was stopped and all patients in the trial were moved to lower dose dexamethasone. Because of the overwhelming positive response to REVLIMID plus low-dose dexamethasone in the ECOG study, a trial from the other large cancer cooperative, SWOG, was also stopped prematurely. This trial compared REVLIMID plus high-dose dexamethasone to dexamethasone alone. Because this SWOG trial stopped early, and because nearly half of the patients on the dexamethasone-alone-arm of the study crossed over to the REVLIMID-plus-dexamethasone-arm of the study within the first year, overall impressions regarding survival could be misleading.
According to Dr. Durie: "We do not want patients confused by statistics. In fact, the SWOG trial concluded that REVLIMID with low-dose dexamethasone is among the most active up-front combination regimens against myeloma. These results demonstrate that REVLIMID plus dexamethasone is definitely better than dexamethasone alone, and is an excellent treatment in newly diagnosed multiple myeloma."
The International Myeloma Foundation concludes that overall findings presented at this conference about multiple myeloma in all ages, and across all categories of patients (newly diagnosed, relapsed, patients proceeding to bone marrow transplants and so on) is positive and encouraging and represents major advances in the treatment of blood cancers beginning with myeloma.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 120 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF was rated as the number one resource for patients in an independent survey by the Target Research Group. The IMF can be reached at (800) 452-CURE, or out of the United States at +1 (818) 487-7455. More information is available at www.myeloma.org.
Media Contact: Stephen Gendel or Jennifer Anderson +1 (212) 918-4650.
Press Contact: Flaherty Chelsey
Company Name:
Phone: 212-445-8274
Website:
Wednesday, April 16, 2008
Medical Device Enables Minimally-Invasive Treatment
FDA Approves Medtronic's TalentT Abdominal Stent Graft for Repairing Aortic Aneurysms
Innovative Medical Device Enables Minimally-Invasive Treatment of Potentially Fatal Condition
MINNEAPOLIS--April 16, 2008--Medtronic, Inc. (NYSE: MDT), today announced approval from the U.S. Food and Drug Administration for use of the TalentT Abdominal Stent Graft on the CoilTrac Delivery System, an innovative medical device that expands patient access to a minimally-invasive treatment option for abdominal aortic aneurysms.
Present in an estimated 1.2 million people and responsible for approximately 15,000 annual deaths in the United States, an abdominal aortic aneurysm (AAA) is a dangerous bulge or weakening of the body's main artery that can rupture with fatal consequences if left untreated. Ruptured AAAs are currently the 10th leading cause of death among U.S. men over age 55, with fewer than 20 percent of people surviving a rupture. But early detection through painless ultrasound screening and minimally invasive treatment with a technique called endovascular repair (EVAR) have historically shown a significant improvement in the survival rate for patients of all ages.
"This important milestone demonstrates Medtronic's leadership and commitment to the field of aortic repair," said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. "Endovascular interventionalists in the United States now have access to the broadest portfolio of stent grafts for the treatment of their AAA patients. The Talent Abdominal System significantly increases the number of AAA patients who can benefit from minimally-invasive repair. As an alternative to open surgical repair, this device will save the lives of many people affected by abdominal aortic aneurysmal disease."
Expanding Indication for EVAR
The Talent Abdominal Stent Graft System makes endovascular repair (EVAR) accessible to an additional 20 percent of AAA patients, because of its unique proximal aortic neck length requirement of only 10 mm. Consisting of a woven polyester membrane supported by a tubular metal lattice, the device is specifically indicated for endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. The stent graft is available in diameters of up to 36 mm, as well as flared and tapered iliac limbs of 8 mm to 24 mm.
With a 12-year history of strong clinical performance including more than 45,000 implants worldwide, the Talent Abdominal Stent Graft is designed to offer broad patient applicability, suprarenal fixation and positioning accuracy. The stent graft features radiopaque markers for visual guidance during deployment and follow up, and the delivery system uses a single-step release mechanism for smooth deployment and a coiled rod for enhanced trackability and flexibility.
"The Talent Abdominal Stent Graft has provided excellent patient outcomes in clinical practice and in clinical study," said Dr. Michael L. Marin, professor of Vascular Surgery and chairman of the Department of Surgery at The Mount Sinai Medical Center in New York. "In my own experience, with more than 750 successful implants using the Talent System, the performance of this stent graft has been very consistent, and its safety and efficacy have been well characterized through the results of our own clinical trial."
Advantages Over Open Repair
The Medtronic-sponsored clinical study of the Talent Abdominal Stent Graft System enrolled 166 patients at 13 medical centers between February 2002 and April 2003. All 166 patients received a Talent Abdominal Stent Graft; their outcomes were compared to those of 243 patients from the Society of Vascular Surgery (SVS) Surgical Control Group at 30 days and one year post-implant. Dr. Frank Criado, director of Union Memorial Hospital's Endovascular Program in Baltimore, was the principal investigator for the study.
The study demonstrated that the Talent Abdominal Stent Graft well exceeded the SVS Control in freedom from major adverse events at 30 days, with a statistically significant difference between the two groups: Talent, 89.2%; SVS Control, 44.0%. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, at 30 days post-implant they experienced lower rates of major adverse events compared with subjects treated with open surgery. Importantly, there were no aneurysm ruptures and no conversions to open surgery in the Talent group up to 12 months after device implantation.
"As Talent is already the leading stent graft for endovascular treatment of AAAs outside the United States, its approval by the FDA is a most welcome and exciting development," Dr. Criado said. "AAA patients in this country can now enjoy the benefits of this device, which has been shown in the pivotal clinical trial to have distinct advantages over standard surgical treatment."
In previous studies, EVAR has been shown to be an effective therapy for AAA, with fewer postoperative complications and shorter recovery times than open surgical repair. Results from a U.S. study published recently in The New England Journal of Medicine (Jan. 31, 2008), for example, indicate that perioperative mortality was significantly lower after EVAR than after open repair: 1.2 percent vs. 4.8 percent - a fourfold difference. Similarly, in a landmark study conducted in the United Kingdom and published in The Lancet (Sept. 4, 2004), the 30-day mortality rate for EVAR patients was 1.7 percent compared to 4.7 percent for patients who underwent open repair - a nearly threefold difference.
Although AAAs typically produce no symptoms until rupturing, they can be detected through a simple, painless and inexpensive ultrasound screening, which is offered free-of-charge to new Medicare beneficiaries. If detected before rupturing, AAAs with diameters of more than twice the size of the normal infrarenal aorta are typically treated with either open surgical repair or endovascular repair (EVAR). In contrast to open surgical repair, EVAR involves a minimally invasive procedure in which a stent graft is threaded through the femoral artery in a compressed state on a delivery system and expanded inside the aorta at the site of the aneurysm. Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm.
As a pioneer of endovascular therapy development, Medtronic has been an innovator and leader in the endovascular stent graft industry for more than a decade, as evidenced by more implants than any other company. Its long history includes more than 130,000 patients treated with stent grafts dating back to 1995. Medtronic currently offers the broadest portfolio of endovascular stent grafts in the industry. These include the AneuRx AAAdvantage® and Talent Abdominal Stent Graft Systems in the United States, and the Talent Abdominal, Talent Thoracic and Valiant® Thoracic Stent Graft Systems outside the United States.
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 27, 2007. Actual results may differ materially from anticipated results.
Contacts
Medtronic, Inc.
Public Relations
Joe McGrath, 707-591-7367
or
Investor Relations
Jeff Warren, 763-505-2696
Wednesday, April 09, 2008
Online Clinical Decision Support Tool Delivers Evidence-based Nursing Information
Wolters Kluwer Health Delivers Evidence-based Nursing Information through Online Clinical Decision Support Tool
Clin-eguide offers direct access to Lippincott Williams & Wilkins trusted nursing information
MINNEAPOLIS--April 09, 2008--Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today that Clin-eguide, its online clinical decision support tool, now offers evidence-based, actionable information for nurses from Lippincott Williams & Wilkins.
Clin-eguide is an online clinical decision support tool that provides accurate evidence-based information for health care providers in the clinical setting. It integrates trusted content from Wolters Kluwer brands like Ovid, Facts & Comparisons®, and Lippincott Williams and Wilkins, as well as other premier publishers.
Through Clin-eguide, nurses have access to a wealth of multi-specialty information that includes evidence-based nursing monographs for disease, drug, treatment, signs and symptoms; the Nursing Drug Handbook database; link to Lippincott's Nursing Procedures and Skills; disease and medication patient handouts; drug information from Facts & Comparisons®; visual differential diagnosis tools; MEDLINE® access; and more.
"Nurses face a myriad of challenges in today's healthcare environment," said Arvind Subramanian, President and CEO, Wolters Kluwer Health Clinical Solutions. "They're tasked with improving patient care and increasing patient safety, all while ensuring compliance with regulatory agencies and helping to educate and mentor incoming generations of nurses."
Subramanian continued, "Clin-eguide nursing solution was designed and created by nurses for nurses. It increases productivity via fast and easy access to evidence-based nursing information and allows nurse educators to better manage limited resources. Plus, it comes backed by trusted nursing content from Lippincott Williams & Wilkins, the leader in evidence-based information for nurses."
About Wolters Kluwer Health
Wolters Kluwer Health (Conshohocken, PA), a division of Wolters Kluwer, is a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry. Major brands include traditional publishers of medical and drug reference tools and textbooks, such as Lippincott Williams & Wilkins and Facts & Comparisons®; electronic information providers, such as Ovid, Medi-Span® and ProVation®; and pharmaceutical information providers such as Adis International and Source®. Wolters Kluwer Health has annual revenues (2007) of $1,044 million (?761 million) and employs approximately 2,700 employees globally. For more information, visit www.WKHealth.com.
Contacts
Wolters Kluwer Health Clinical Solutions
Media Contact:
Laura Gilbert, 612-313-1506
Director, Marketing Communications
laura.gilbert@wolterskluwerhealth.com
Wednesday, April 02, 2008
Healthcare News Network Adds to Team
Recent hires in management, creative development, production and sales have the company ready to soar to new heights.
Cape Coral, Florida (PRWEB) December 13, 2007 -- Healthcare News Network (www.healthcarenewsnetwork.com) is expanding their team. Recent hires in management, creative development, production and sales have the company ready to soar to new heights.
Joann Ellis has been named General Manager and brings with her a diverse background to expand the network. Joann graduated Magna Cum Laude from The Ohio State University with a Masters degree in Quantitative Analysis and Measurement. Joann's background experience includes consulting for Ohio Collaborative, a group specializing in research for state agencies and writing briefs for the Ohio Senate and lobbying groups, as well as Titan Financial Group in Atlanta where she created and facilitated employee training programs and developed models for risk management.
Gregory Bush, Healthcare News Network CFO, is responsible for the financial reporting and technical infrastructure of the network. Greg brings with him over 20 years of management, financial and systems experience from both private and public companies, including Colorworks, Morgenthau and Bush Industries. A graduate of State University of New York Fredonia, Greg holds a degree in Business Management and Computer Engineering.
Juan Andres Rodriguez, named HNN's Creative Director, is a talented graphic artist and develops the feel of the network. A Cum Laude graduate of Eastern Connecticut State University, Juan has a passion for life, well-being and happiness which translates into the mission of the Healthcare News Network. Juan has worked for such advertising agencies as Leo Burnett and Grupo Z in Mexico and was a part of the launch of Zombra, a below-the-line advertising agency also based out of Mexico. Juan is part owner of Baja Design Studios in Baja California, Mexico, a freelance design studio specializing in the image and promotion of new businesses throughout the area.
Michael Shapiro, VP Director of Programming, is responsible for the content and substance of the network. He is committed to acquiring video material and public service announcements from non-profit organizations to help promote local and national charities. Mike has a diverse background with nearly 30 years of television experience in news, production, management, producing and videography. He has worked at television stations in South Dakota, Iowa, and cities in Florida including Fort Myers, Tampa and Miami. He is an award-winning producer of spot news, features, documentaries and a national Addy for a PSA. Giving back to the community is important to Mike and he is a member of several advisory boards including The School of Nursing at Florida Gulf Coast University, The Nations Association and the PACE Center for Girls. Mike graduated Summa Cum Laude from Adelphi University.
Shirley Stone, HNN's National Sales Manager, has over 20 years in the New York advertising industry. She has worked for ad agencies, media departments and started her sales career in magazines - Redbook and Cosmopolitan. In the early 1980's she switched from magazines to the just emerging cable TV industry and was a member of the first MTV sales team. From there she moved on to working for Ted Turner at CNN and then the first New York Director of Sales for The Discovery Channel where she managed a team of account executives and sales support people. Disillusioned with the corporate environment she started a media consulting business and worked on the launch of The Food Network, several Internet companies and By Kids For Kids, a kids innovation company. She holds both a BBA and MBA in marketing, is a graduate of the Communispond Public Speaking Course and is a certified Empowerment Life Coach.
The Healthcare News Network started with less than 10 employees writing, producing, shooting, editing and distributing its programming just one year ago. They now house a team of over 30 employees in three states and will continue to grow along with the success of the nationwide network.
About the Healthcare News Network
The Healthcare News Network, a hospital-exclusive Out-of Home Media Network, was launched in February of 2007 and is based out of Cape Coral, Florida. HNN is the first of its kind to bring customizable, positive healthcare news to each hospital in its network. Currently, HNN is airing in 34 hospitals across Florida with the expansion to 23 states and over 200 hospitals expected to be complete by 2008.
For more information, visit our website: www.healthcarenewsnetwork.com
Or call our office toll free: 800 446 7575
Contact:
Rachel Tramonte
Healthcare News Network
800 446 7575
239 549 4176
rachel @ healthcarenewsnetwork.com
www.healthcarenewsnetwork.com
Press Contact: Rachel Tramonte
Company Name: Healthcare News Network
Phone: 800-446-7575
Website: www.healthcarenewsnetwork.com