NASDAQ OMX

Vascular Dynamics Announces FDA Approval to Initiate CALM 2 Trial for MobiusHD® System for the Treatment of Resistant Hypertension

Dela

MOUNTAIN VIEW, Calif., Aug. 15, 2017 (GLOBE NEWSWIRE) -- Vascular Dynamics, Inc., (VDI) a privately held medical device company developing novel solutions for the treatment of hypertension, today announces that the United States Food and Drug Administration (FDA) has approved the company's Investigational Device Exemption (IDE) application to initiate its pivotal trial for its MobiusHD® System for the treatment of resistant hypertension.

The CALM (Controlling and Lowering Blood Pressure with MobiusHD) 2 trial is a multi-center, prospective, randomized, double-blind, sham-controlled pivotal study designed to evaluate the safety and effectiveness of the MobiusHD System. The company will evaluate patients from select locations throughout the United States whose hypertension remains uncontrolled despite using three or more anti-hypertensive pharmacologic therapies.  VDI also intends to conduct the CALM 2 trial in certain European countries following appropriate regulatory authorization.

"The rigor and scientific focus of the Calm 2 trial has been crafted and improved from much of what we learned from prior studies. Calm 2 will offer patients a therapeutic alternative and a level of medical monitoring to which they otherwise would never have access outside of a clinical trial," said Bryan Williams co-Principal Investigator of the Calm 2 trial and Chair of Medicine at University College London and Director of the NIHR UCLH/UCL Biomedical Research Centre and Director of Research at UCL Hospitals. He is Chairman-Elect of the European Council on Hypertension of the European Society of Cardiology.

"In clinical practice, we are regularly faced with those hypertension patients who simply do not respond to medication or lifestyle changes.  Initiating this trial is an important step toward identifying additional viable treatments to help this large population of patients," said Gregg Stone, MD, Co-Principal Investigator of the CALM 2 trial and director of cardiovascular research and education for Columbia University Medical Center/New York-Presbyterian Hospital and co-director of medical research and education at the Cardiovascular Research Foundation.

The company has been chosen as a participant in the FDA's Expedited Access Pathway (EAP) program, a focused initiative to significantly accelerate access for US patients and their physicians to innovative medical treatments. VDI is also one of only nine companies chosen for the FDA's Early Feasibility Study Investigational Device Exemptions (IDE) Pilot Program, which enables companies to conduct smaller-scale studies under the guidance of the Agency in the United States in order to meet the requirements for an earlier pathway toward approval.

"Initiating the CALM 2 trial is an important milestone for Vascular Dynamics as it allows us the opportunity to demonstrate the potential utility of our technology in a significant patient population," said Robert Stern, president and CEO of Vascular Dynamics.  "With our participation in both the EAP and IDE programs, we also have the unique opportunity to work closely with the FDA to ensure a more rapid start to the trial while still maintaining the high standards of safety, efficacy and scientific validity required by the program."

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. 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 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.

Contact:
Jules Abraham
917-885-7378
jabraham@vasculardynamics.com

 
 



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 originality of the information contained therein.
Source: Vascular Dynamics, Inc. via Globenewswire

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.

Senaste pressmeddelandena från NASDAQ OMX

Abiomed Receives FDA PMA Approval for Impella RP® for Right Heart Failure21.9.2017 00:23Pressmeddelande

DANVERS, Mass., Sept.  20, 2017  (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP® heart pump. Culminating from five years of research, this approval follows the prior FDA Humanitarian Device Exemption (HDE) received in January 2015 and adds the Impella RP heart pump to Abiomed's platform of PMA approved devices. With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure as stated in the indication: The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area greater than or equal to 1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device impl

Senegal and France to host Global Partnership for Education Financing Conference20.9.2017 23:00Pressmeddelande

NEW YORK, Sept. 20, 2017 (GLOBE NEWSWIRE) -- The Global Partnership for Education (GPE) is delighted that the governments of Senegal and France will co-host its financing conference, which will take place on February 8, 2018 in Dakar, Senegal. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/d3003cff-ee20-409f-9729-9a9cef1d4d3e A video accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0a7eebb6-66b3-438b-904e-efeff83d94cf The announcement of the co-hosting was made by Presidents Macky Sall of Senegal and Emmanuel Macron of France at a high-level event on education financing held at the United Nations, which was attended by Secretary General António Guterres, several heads of state and leaders on global education. " The Global Partnership for Education has   made substantial investments in education helpin

K2 Launches New Process Automation Platform Including New Cloud Service20.9.2017 18:00Pressmeddelande

K2's process automation platform allows businesses of all types around the globe to rapidly build and deploy automation across the business. BELLEVUE, Wash., Sept. 20, 2017 (GLOBE NEWSWIRE) -- K2 today announced the availability of its new low-code process automation platform - furthering innovation in the way organizations drive digital efficiencies. With a new managed cloud service, K2 Cloud, new on-premises version, K2 Five, and completely redesigned user interfaces and experiences, the platform helps businesses of all types around the globe rapidly deliver powerful process automation and realize business productivity gains. Automating business processes across an enterprise is crucial to the success of companies in the era of digital transformation. However, many initiatives are impacted by a lack of sufficient resources and the use of inefficient systems to manage processes. K2's low-code process automation platform solves these problems by enabling organ

8x8 and Aryaka Partner to Enhance Cloud Communications for Global Enterprises20.9.2017 16:43Pressmeddelande

Strategic Alliance will improve communications experience for business users worldwide SAN MATEO, Calif., Sept. 20, 2017 (GLOBE NEWSWIRE) -- Aryaka®, the leading global SD-WAN provider, and 8x8, Inc. (NASDAQ:EGHT), the world's first Communications Cloud provider, today announced that they are entering a strategic partnership that will improve the performance and reliability of business-critical cloud unified communications. This will enable global mid-market and enterprise companies to enhance business communications, collaboration and customer engagement for their employees, customers and partners around the world. Through this partnership, Aryaka's global SD-WAN solution will provide enterprise-grade private connectivity to further enhance the superior voice and video quality delivered by the 8x8 Communications Cloud(TM). When tested against several leading Unified Communications as a Service (UCaaS) providers, 8x8 was recently found by the Tolly Group to deliver the hi

NRT Technology Corp and Gaming Payments Innovator Sightline Payments Announce Merger20.9.2017 16:00Pressmeddelande

Combination Will Accelerate Innovation in Mobile, Data, Cashless Payments, and Provisional Credit Solutions to the Worldwide Integrated Resort Casino Industry LAS VEGAS, Sept. 20, 2017 (GLOBE NEWSWIRE) -- NRT Technology Corp. ("NRT") a leading provider of integrated ticket redemption and payment services to global casino operators, and Sightline Payments ("Sightline"), developers of the disruptive Play+ platform that's powering the next generation of cashless and mobile gaming payment solutions, announced today an agreement to merge.  The company on closing will be named NRT Sightline and will form one of the largest pure play gaming payment technology companies in the world with an equity value of over $300 million. Following the closing of the transaction and subject to regulatory approvals, Sightline's CEO and Founder, Kirk Sanford, will assume the role of President and CEO of NRT Sightline.  NRT's current Founder, P

BT and Hitachi Partner to Develop Industrial and Enterprise IOT Solutions20.9.2017 15:00Pressmeddelande

Initial Focus on Asset Intelligence and Predictive Maintenance Use Cases LAS VEGAS and LONDON, Sept. 20, 2017 (GLOBE NEWSWIRE) -- BT, one of the world's leading providers of communications services and solutions, and Hitachi Vantara, a wholly owned subsidiary of Hitachi Ltd. (TSE:6501) today announced a global partnership to co-create innovative solutions in the area of industrial and enterprise internet of things (IoT). The partnership aims to drive better business outcomes for global customers, including greater efficiency, productivity and cost savings. The companies will initially focus on exploring and designing asset intelligence and predictive maintenance solutions to deliver the desired outcomes for customers in industry sectors such as manufacturing and transportation. Announced at Hitachi's inaugural user conference, Hitachi NEXT 2017, in Las Vegas today, the partnership unites BT's global network infrastructure, cloud capabiliti

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum