Interim Data on MobiusHD Presented at the European Society of Cardiology Shows Promise in the Treatment of Resistant Hypertension
MOUNTAIN VIEW, Calif., Aug. 28, 2017 (GLOBE NEWSWIRE) -- Vascular Dynamics, Inc., (VDI) a privately held medical device company developing novel solutions for the treatment of hypertension, today announced interim results of the company's first-in-human trial of its MobiusHD implant presented in a podium presentation at the European Society of Cardiology (ESC) in Barcelona. The data showed an average reduction of ambulatory systolic blood pressure of 20 mmHg from baseline in the first 40 patients (of an anticipated 50) to reach the 6-month endpoint in studies conducted in the US and EU.
These interim results of the CALM-FIM (Controlling and Lowering Blood Pressure with MobiusHD First in Man) trial, provided results from the first cohort of 40 patients evaluated in the United States and Europe. The data demonstrated that at the six-month evaluation point, 88 percent of the 40-patient cohort had a greater than 10 mmHg drop in office systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure. Many of these patients also experienced a reduction in their use of antihypertensive medication.
"These interim data show significant promise in treating patients with resistant hypertension, that is, those who remain uncontrolled even after as many as three or more antihypertensive drugs," said Wilko Spiering, MD, internist-vascular medicine specialist, University Medical Center Utrecht, the Netherlands and President of the Dutch Hypertension Society who presented the CALM-FIM data as one of the trial investigators. "Our positive experience with the MobiusHD device demonstrates the need for continued investigation in a sham-controlled setting, which is currently running in the Netherlands and is starting up in the United States, United Kingdom, and Germany shortly."
The interim results presented at the ESC conference will be followed by a study to be published in The Lancet on September 1, 2017, which outlines the final results of the CALM-FIM_EU study.
The MobiusHD System, a minimally-invasive system, capitalizes on the ability of the body's baroreceptor mechanism to regulate blood pressure. Baroreceptors are receptors located in the carotid artery that sense blood pressure and relay that information to the brain. The MobiusHD implant is designed to amplify the signals received by the surrounding arterial baroreceptors, and thereby increase the body's natural response to lower blood pressure through vasodilation.
About Resistant Hypertension
Hypertension, or elevated blood pressure, is a common medical condition that currently affects one billion people worldwide.1 If left untreated, hypertension can cause life-threatening problems, including heart attack, aneurysm, stroke or kidney failure. Patients with hypertension can often reduce their risk factors by making lifestyle changes such as losing weight, quitting smoking, and increased exercise. In cases with advanced hypertension, medical therapies may be prescribed.
Patients experiencing resistant hypertension are uncontrolled with at least 3 antihypertensive drugs and are at four times greater risk of cardiovascular events compared with hypertensive patients achieving blood pressure targets.2 The American Heart Association (AHA) estimates that high blood pressure costs the U.S. $46 billion each year, including the cost of healthcare services, medications to treat high blood pressure, and lost productivity.
About Vascular Dynamics, Inc.
Vascular Dynamics develops catheter-delivered technologies to bring a better quality of life to patients who are resistant to conventional treatments for hypertension. The device is covered by seven issued and pending U.S. and international patents. The MobiusHD system has received a CE Mark for the treatment of hypertension in the European Union. However, the MobiusHD system is not commercially available in the United States. More information is available at www.vasculardynamics.com.
CAUTION: In the United States, the MobiusHD Device is limited by law to investigational use only.
1 Kearney PM, et al. Global burden of hypertension: Analysis of worldwide data. Lancet. 2005;365(9455):217-23
2 Pierdomenico SD, Lapenna D, Bucci A, et al. Cardiovascular outcome in treated hypertensive patients with responder, masked, false resistant, and true resistant hypertension. Am J Hypertens. 2005;18: 1422-8.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Vascular Dynamics, Inc. via Globenewswire
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39 | Pressmeddelande
DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s
Second Quarter 2018 Results Conference Call19.7.2018 21:34 | Pressmeddelande
AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 www.magna.com Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations email@example.com, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations firstname.lastname@example.org, 905-726-7108 This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originali
Uganda National Airlines Company Limited Signs Firm Order for Four Bombardier CRJ900 Aircraft19.7.2018 18:36 | Pressmeddelande
First operator of the new CRJ Series ATMOSPHÈRE cabin in Africa MONTREAL, July 18, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft announced today that it has signed a firm order for four new CRJ900 regional jets with Uganda National Airlines Company. Based on the list price for the CRJ900 aircraft, the firm order is valued at approximately US$190 million. "We congratulate the Government of Uganda for the revival of its national flag carrier, and are thrilled that the new airline has selected Bombardier and the CRJ900 regional jets for its upcoming debut," said Jean-Paul Boutibou, Vice President, Sales, Middle-East and Africa, Bombardier Commercial Aircraft. "Recognized for its superior economics and efficiency, the CRJ Series aircraft have enabled airlines worldwide to serve communities with better connectivity, and we look forward to supporting the development of Uganda's regional air travel with these CRJ900 regional jets." Uganda Airlines will operate the CRJ900 in dual-cla
CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03 | Pressmeddelande
"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil
Jumio Introduces Liveness Detection for Web to Better Deter Fraud During Account Onboarding19.7.2018 14:00 | Pressmeddelande
New identity proofing functionality ensures that the person behind a Web upload verification is present and the person actually creating a new online account PALO ALTO, Calif., July 19, 2018 (GLOBE NEWSWIRE) -- Jumio, the creator of Netverify(TM) Trusted Identity as a Service (TIaaS), today announced the addition of Liveness Detection for Web to better thwart fraudsters' evolving and sophisticated attempts to assume another individual's identity. With identity verification, Jumio's approach is to first verify the government-issued ID (e.g., driver's license, passport or ID card) and ensure that it is authentic and has not been doctored. For mobile SDK customers, Jumio then requires the user to take a selfie which enables the company to compare the person in the selfie to the person pictured in the ID document. Since Netverify is an omnichannel solution, Jumio also supports identity verification via desktop webcams. This channel enables our customers to reach large market segments who a
Northland Power Adds 17MW of Capacity to the Deutsche Bucht Offshore Wind Farm19.7.2018 12:33 | Pressmeddelande
TORONTO, July 19, 2018 (GLOBE NEWSWIRE) -- Northland Power Inc. ("Northland") (TSX:NPI) announced today that the Deutsche Bucht Mono Bucket pilot demonstrator ("Demo") project has reached financial close. All required funds for the Demo project have been contributed by Northland and committed by the project lenders. In May, the Federal Maritime and Hydrographic Agency of Germany (BSH) granted the Deutsche Bucht offshore wind project the permit required to erect two additional pilot wind turbines using Mono Bucket foundations. Deutsche Bucht will be the first offshore wind farm worldwide to test this new type of foundation structure under commercial operating conditions. As previously announced, the two turbines will contribute an additional 17 MW of capacity to the base 252 MW project for a total of 269 MW and bringing the total project cost to approximately €1.4 billion (CAD $2.0 billion) - up from €1.3 billion. Northland's corporate investment has increased from approximately $400 mi
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum