Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device
Publication Follows Positive Interim Results in US and EU Patients Presented at the European Society of Cardiology Conference
MOUNTAIN VIEW, Calif., Sept. 01, 2017 (GLOBE NEWSWIRE) -- Vascular Dynamics, Inc. (VDI), a privately held medical device company developing novel solutions for the treatment of hypertension, today announced European results of the company's first-in-human trial of its MobiusHD® implant published in The Lancet. The publication reported an average reduction of 24-hour ambulatory systolic blood pressure of 21 mmHg from baseline in the 30 European patients 6 months after implantation. Moreover, the Study authors reported that implantation of the MobiusHD device was straightforward for experienced interventionists, with a 100 percent procedural success rate.
The Lancet publication, which was posted today online, noted that the CALM-FIM_EUR study was a first-in-human feasibility study in which 30 patients were enrolled at 6 European centers in the Netherlands (5) and Germany (1) between December 2013 and February 2016. All patients had resistant hypertension, defined as office systolic blood pressure above 160 mmHg, despite the use of three or more antihypertensives, including a diuretic. The MobiusHD devices were implanted unilaterally in the internal carotid artery. Mean office blood pressure was 184/109 mmHg at baseline and was reduced by 24/12 mm Hg at 6 months. Mean baseline 24-hr ambulatory blood pressure was 166/100 mmHg at baseline and was reduced by 21/12 mmHg at 6 months despite an observed reduction in hypertensive medication. The investigators reported 6 serious adverse events, all of which were reported to have resolved without sequelae.
"These published results of the CALM-FIM_EUR study demonstrate that the MobiusHD device may significantly reduce both office and ambulatory blood pressure among patients on three or more drugs who have been unable to control their hypertension," said Wilko Spiering, MD, internist-vascular medicine specialist, University Medical Center Utrecht, the Netherlands and President of the Dutch Hypertension Society, lead author of the study. "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 Lancet publication comes immediately following the presentation of interim results of the CALM-FIM trials (US and EU study data) at a podium session at the 2017 Annual Congress of the European Society of Cardiology in Barcelona by Dr. Spiering.
"These results present a potentially significant advance in the treatment of hypertension, particularly with regard to those patients whose blood pressure has remained uncontrolled despite lifestyle changes and multi-drug therapy," said Dr. Bryan Williams, co-Principal Investigator of the CALM 2 trial from University College London (UCL) Institute of Cardiovascular Science and National Institute for Health Research UCL Hospitals Biomedical Research Centre. He is also Chairman of the European Council on Hypertension of the European Society of Cardiology. "We hope that continued study in the upcoming CALM 2 trial will continue to garner the results we've seen thus far, which will provide an important addition to our approach to controlling this incredibly pernicious and deadly disease."
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.
"The benefit of a minimally invasive therapy that can reduce ambulatory blood pressure significantly in these truly resistant patients, including those that have failed renal denervation, has always been our goal," said Robert Stern, president and CEO of Vascular Dynamics Inc. "With these positive results, we will now press on to gather the sham randomized controlled data to ensure that the MobiusHD can impact patient care positively."
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. Resistant hypertension cannot be controlled with medical therapies. Patients experiencing resistant hypertension 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 ten 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
PayByPhone appoints Andreas Gruber as new President and CEO20.4.2018 00:19 | Pressmeddelande
VANCOUVER, British Columbia, April 19, 2018 (GLOBE NEWSWIRE) -- PayByPhone, the global leader in mobile parking payments, today announced that it will appoint Andreas Gruber as president and Chief Executive Officer effective June 1st, 2018. Francis Dupuis, the former President and CEO, will take over a position in Germany with parent company Volkswagen Financial Services AG. To provide additional impetus to the PayByPhone board, two new board positions have been created and as a result Maggie Clay (CFO) and Catherine Scott (Legal Counsel) will be appointed effective June 1st, 2018. During his time at PayByPhone, Francis led the business through significant growth and organizational change and leaves the company well positioned for continued success. "We would like to thank Francis for his strong leadership and look forward to building on his experience within Volkswagen Financial Services," Gerd Künne, Vice-President of mobility unit at Volkswagen Financial Services, said. Francis is e
Progress and Potential for Achieving Cleaner Air on a Global Basis20.4.2018 00:09 | Pressmeddelande
Adoption of New Generation Diesel Technology Delivers Rapid Clean Air Benefits New understanding of global air quality highlights the need for technologies like new-generation diesel engines, which are capable of accelerating emissions reductions WASHINGTON, April 19, 2018 (GLOBE NEWSWIRE) -- Recent reports highlighting air quality conditions in the United States (State of the Air) and globally (State of Global Air 2018) celebrate the progress made in developed and developing countries, but also emphasize significant disparities in progress toward reducing levels of key pollutants such as particulate matter and ozone. "Achieving continued clean air progress while also sustaining economic growth is possible. Cities and countries must move to proven cleaner engines and fuels," said Allen Schaeffer, executive director of the Diesel Technology Forum. "We can and should bring the tremendous benefits of new technology diesel engines to communities and countries large and small around the wor
SD-WAN for Office 365: Aryaka Helps eLearning company, City & Guilds Group, Improve Office 365 Application Response Time19.4.2018 18:54 | Pressmeddelande
Aryaka's Global SD-WAN reduces time for global users to open SharePoint files from 10 to 0.05 seconds; Outlook performance improves 9x worldwide LONDON, April 19, 2018 (GLOBE NEWSWIRE) -- Aryaka®, the leading global SD-WAN provider, announced today its SD-WAN technology has enabled City & Guilds Group, a worldwide leader in workplace skills, eLearning, and executive coaching, to achieve faster Office 365 application response times leading to an increase in productivity and better collaboration between users in Europe and Asia-Pacific. Headquartered in London, the City & Guilds Group works with education providers, governments and major corporations to help shape and support skills development for employers in over 100 countries. Team members of the company are similarly scattered around the world and primarily collaborate using Microsoft Office 365 applications, but many remote users were struggling to access the group's instance of Office 365 hosted in Dublin. For example, it could ta
Canacol Energy Ltd. Announces Private Offering of Senior Notes19.4.2018 16:23 | Pressmeddelande
CALGARY, Alberta, April 19, 2018 (GLOBE NEWSWIRE) -- Canacol Energy Ltd. ("Canacol" or the "Corporation") (TSX:CNE) (OTCQX:CNNEF) (BVC:CNEC) is pleased to announce that it intends, subject to market and other conditions, to offer senior unsecured notes (the "Notes") in a private placement to qualified institutional buyers in the United States pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), to non-U.S. persons in transactions outside the United States pursuant to Regulation S under the Securities Act and pursuant to certain prospectus exemptions in Canada (the "Offering"). The Notes will be fully and unconditionally guaranteed by certain subsidiaries of Canacol. The interest rate, redemption prices and other terms of the Notes are to be determined upon pricing of the Offering. Canacol intends to use the net proceeds from the Offering: (i) to repay the outstanding amounts borrowed under its credit facility; (ii) to pay fees and expenses of the O
FinancialForce Extends Professional Services Automation Leadership With its Spring 2018 Release19.4.2018 14:00 | Pressmeddelande
New features empower services organizations to run their businesses with greater predictability, assign best-fit resources at scale, and forecast projects with 360-degree insight. SAN FRANCISCO, April 19, 2018 (GLOBE NEWSWIRE) -- FinancialForce, the number one customer-centric ERP cloud vendor built on the Salesforce Platform, announced the availability of its latest version of Professional Services Automation, the highest customer-rated PSA solution for enterprise organizations. The Spring 2018 Release of PSA brings new functional capabilities to accelerate project staffing speed and accuracy; unify people and project data; enable better forecasting decisions; and enhance the overall user experience using the Salesforce Lightning framework. Fast, Accurate Resource Mapping With the Spring 2018 Release of PSA, project and resource managers can identify and assign best-fit resources with greater speed and accuracy. Through advanced skills filtering and search capabilities, including part
SpeeDx receives FDA clearance for Mycoplasma genitalium product19.4.2018 14:00 | Pressmeddelande
SYDNEY, Australia, April 19, 2018 (GLOBE NEWSWIRE) -- SpeeDx's Resistance Plus ® MG Positive Control kit has now been listed with the US Food and Drug Administration (FDA) for sale in the United States through the company's recently incorporated US entity, SpeeDx Inc. The announcement coincides with the FDA registration of the Australian parent company - SpeeDx Pty Ltd - as a Medical Device Manufacturing Establishment, and clinical trials remain on-track for the Resistance Plus MG assay.* The Resistance Plus MG Positive Control kit contains synthetic DNA to simulate Mycoplasma genitalium, as well as five mutations known to confer resistance to macrolide antibiotics. Macrolide-resistant M. genitalium is a challenging sexually transmitted infection (STI), and global management guidelines are currently being adapted to deal with the rise in resistance. "This is an important product in our portfolio," said Elisa Mokany, Chief Technology Officer for SpeeDx. "M. genitalium is very difficult
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum