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
Fura Completes Acquisition of Colombian Emerald Mine, Coscuez22.1.2018 13:00 | Pressmeddelande
TORONTO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Fura Gems Inc. (TSXV:FURA) is pleased to announce that it has completed its acquisition of 76% of the issued and outstanding shares of Esmeracol S.A. ("Esmeracol"), which owns a 100% interest in mining licence no. 122 - 95M (the "Coscuez Licence"). Dev Shetty, President & CEO of Fura, commented: "Fura has achieved one more important milestone by adding the iconic Colombian emerald mine, Coscuez, to its portfolio. With this acquisition, Fura now has two important silos in its portfolio, Colombian emeralds and Mozambican rubies. Fura will now work towards modernisation of the Coscuez emerald mine and deployment of the best health and safety standards for its employees while keeping the environmental impact minimal. Fura will also closely work with the local community and relevant authorities to promote the social-economic development in the region. We would like to thank our local partner and also the entire team on the ground in the Colombia fo
Agency for the Cooperation of Energy Regulators (ACER) continues to use Nasdaq's SMARTS for Pan-European Market Monitoring of EU Wholesale Energy Markets22.1.2018 12:30 | Pressmeddelande
NEW YORK, Jan. 22, 2018 (GLOBE NEWSWIRE) -- The Agency for the Cooperation of Energy Regulators (ACER) has officially extended its contract with Nasdaq (Nasdaq:NDAQ) to continue to leverage Nasdaq's SMARTS Market Surveillance technology to detect insider trading and market manipulation across the European Union's wholesale energy markets by digesting and analyzing massive volumes of data from hundreds of power producers, exchanges, operators, and brokers across 28 member states. The new agreement contract extension will continue to allow national regulatory authorities to share data, technology, and expertise, with the aim of creating a cooperative regulatory infrastructure. Under the contract, SMARTS technology will continue being leveraged to monitor the European wholesale gas and electricity markets, covering both spot trading and derivative markets across Europe in accordance with the obligations under the REMIT legislation. Further, the surveillance technology will support ACER's
Bell Canada Reaches Milestone in Network 3.0 Vision with Open Network Automation Platform (ONAP) and Strategic Partnership with Amdocs22.1.2018 12:00 | Pressmeddelande
Bell's leadership in bringing open source ONAP into production enables innovative new offerings to customers faster and at lower cost ST. LOUIS, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Amdocs (NASDAQ:DOX), a leading provider of software and services to communications and media companies, today announced that Bell, Canada's largest communications company, has successfully implemented the first network automation use case in production leveraging the Linux Foundation's Open Network Automation Platform (ONAP). As Bell's strategic partner, Amdocs brings unparalleled ONAP expertise and DevOps scrum team agility and delivery capabilities with the goal of driving innovation faster and reducing the cost of building and operating the data center of the future. With clear benefits such as a more elastic network and increased business agility to be gained from taking advantage of network functions virtualization (NFV), Bell is driving its network transformation by leveraging the ONAP-based network serv
Alvogen CEO Robert Wessman speaks exclusively to World Finance about new opportunities in generic pharmaceuticals22.1.2018 11:51 | Pressmeddelande
LONDON, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Industry disruptor Robert Wessman, the CEO of rapidly growing generic pharmaceuticals company Alvogen, shares his thoughts on the latest market trends in the new edition of World Finance magazine. Only different in name and price, generic pharmaceuticals in the US are a whopping 50 to 70 percent less expensive than their branded equivalents. Unsurprisingly, in an era of ever-rising medical costs, a growing number of governmental entities and corporations are now choosing generics over branded pharmaceuticals. For some time, just a handful of big-name organisations dominated this nascent market. But, following its peak in 2015, over-valuations have prompted vulnerability, opening the door for new, more nimble competitors to join and disrupt the market. Among this innovative group of 'next generation' pharmaceutical companies is Reykjavik-based Alvogen. Though it was only established in 2009, this global-facing organisation now boasts an annual t
Hat-trick for LeoVegas at EGR Nordics Awards 201822.1.2018 08:00 | Pressmeddelande
The most successful and innovative gaming companies are noticed at the EGR Nordic Awards. In fierce competition, LeoVegas won three awards, "Nordics Operator of the Year", "Casino Operator of the Year" and "Sports Betting Operator of the Year". "We are extremely pleased to have won the Casino Operator and the Sports Betting Operator awards as these are the two main categories that define our product. Being declared as the Nordics Operator of the Year is really outstanding! To receive these awards is a receipt that we are an extremely talented team at LeoVegas that is constantly delivering. It also shows that we are the GameTech company that is leading the way within the Nordic region," says Gustaf Hagman, Group CEO. Nordics Operator of the Year LeoVegas won the award for the Nordics Operator of the Year because LeoVegas has been the driving force for innovation in all parts of the company and clearly distinguished from its competitors through a mix of high growth, innovation and strong
Immunicum AB (publ) meddelar kommande presentationer och deltagande i konferenser under januari och februari22.1.2018 08:00 | Pressmeddelande
Pressmeddelande 22 januari 2018 Immunicum AB (publ) meddelar kommande presentationer och deltagande i konferenser under januari och februari Immunicum AB (IMMU.ST), ett bioteknikbolag som utvecklar nya immunostimulerande cancerbehandlingar för ett antal solida tumörformer, meddelar idag att Immunicums ledning kommer att presentera bolaget och delta under flera kommande branschkonferenser och forskningskonferenser under januari och februari. ASCO/SITC - Clinical Immuno-Oncology Symposium Datum: 25-27 januari 2018 Plats: San Francisco Marriott Marquis, San Francisco, Kalifornien, USA Aktiedagen Lund Datum: 30 januari 2018 Presentation: tisdag den 30 januari, 10:15 CET Plats: Medicon Village, Hörsalen Scheelevägen 2, Lund För att delta, registrera dig här https://www.aktiespararna.se/aktiviteter/aktiedagen-lund-30-januari Cholangiocarcinoma Foundation Annual Conference Datum: 31 januari-2 februari 2018 Presentation: Poster Session: torsdag den 1 februari, kl. 19:00-21:00 Mountain Standard
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum