HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS CONFERENCE CALENDAR
LATEST UPDATES » Vol 21, No 12, December 2017 – Skin diseases and allergic reactions       » Gigantic DNA database to be built in Nanjing       » Ineffective baby vaccines by two companies recalled       » Head transplant 'never' to be allowed       » Asia-Pacific, the rising region for cancer vaccine clinical trials       » The hard truth about Eczema      
INSIDE INDUSTRY
Vascular Dynamics receives FDA approval to begin conclusive and pivotal trial experimentation for treatment of chronic hypertension
The experiment will examine the effectiveness of the MobiusHD implant in the reduction of blood pressure among chronic patients for whom at least three different medications proved ineffective.

Vascular Dynamics, a medical device company currently developing an innovative treatment for hypertension and one of the leading principals of the Rainbow Medical Investment Cluster, announced that the Food and Drug Administration (FDA) approved the company's plans to initiate conclusive and pivotal trial experimentation to investigate the effectiveness of its flagship product, MobiusHD, in the treatment of chronic hypertension.

Vascular Dynamics was chosen by the FDA to participate in an accelerated EAP (Expedited Access Pathway) program, the objective of which is to catalyze innovative and life-saving experimental treatments, as a means of bringing them to clinical use among patients as soon as possible. In addition, the company is one of nine companies chosen for participation in an IDE (Investigational Device Exemptions) pilot program, to enable the execution of experiments on a smaller scale and an expedited pathway to FDA marketing approval.

MobiusHD, a miniature invasive implant, changes the way by which patients who do not respond to medications for reducing hypertension are treated. The implant is inserted by means of a catheter and placed in the carotid, in a location containing baroreceptor nerves that regulate the heart's output, thereby regulating the body's blood pressure. Whenever these sensors are damaged, the brain receives erroneous commands that cause the increase in blood pressure. The implant developed by Vascular Dynamics enhances the sensors' signals and improves blood pressure regulation.

Efi Cohen-Arazi, CEO of Rainbow Medical, said, "We are pleased to have received such a meaningful expression of faith from the FDA for the Vascular Dynamics solution. Experimenting within the EAP framework emphasizes the medical need and recognition of the innovative solution we have developed. This pathway can significantly shorten the product's time to market and bring relief to millions of patients worldwide coping with chronic hypertension and drug resistance."

The pivotal study, CALM 2 (Controlling and Lowering Blood Pressure with MobiusHD), taking place in the United States and for the first time in Europe, is intended to examine the effectiveness of MobiusHD in controlling, regulating and lowering high blood pressure in chronically ill patients who, although they have received multiple hypertension medications, saw no improvement in their condition. It is one of the most common phenomena in medicine yet to find a sufficient pharmaceutical or technological response.

"The experiment is an extremely important milestone, in which we will be able to confirm the latent potential in our technology for the treatment of this enormous global population, and prove that MobiusHD is capable of changing and saving lives," added Robert Stern, President and CEO of Vascular Dynamics.

Source: Vascular Dynamics and Rainbow Medical

Click here for the complete issue.

NEWS CRUNCH  
news Biology of Ageing II - Impactful Interventions
news Separation of conjoined twins presents surgical and ethical challenges for MassGeneral Hospital for Children staff
news MIT Technology Review announces 2018's 10 'Innovators Under 35 Asia'
PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  

Lady Ganga: Nilza'S Story
COLUMNS  
Subscribe to APBN E-Newsletter
Find us under 'Others' option to receive APBN e-newsletters thrice a month!

APBN Editorial Calendar 2017
January:
Healthcare Focus: LUNGS
February:
War on CANCER
March:
Get to Know TCM
April:
Diabetes: The Big Picture
May:
The Piece of Your Mind - Brain Health/Science
June:
Advocacies in Support of Rare Disease Patients
July:
Food Science & Technology
August:
Eye – the Window to your Soul
September:
Infectious Diseases
October:
A change of heart — Cardiovascular diseases
November:
Paediatric Illnesses
December:
Skin Diseases and Allergic Reactions
Editorial calendar is subjected to changes.
MAGAZINE TAGS
About Us
Events
Available issues
Editorial Board
Letters to Editor
Instructions to Authors
Advertise with Us
CONTACT
World Scientific Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
Tel: 65-6466-5775
Fax: 65-6467-7667
» For Editorial Enquiries:
   biotech_edit@wspc.com or Ms Lim Guan Yu
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   biotech_ad@wspc.com
Copyright© 2017 World Scientific Publishing Co Pte Ltd  •  Privacy Policy