Navigation Links
Mardil Inc. Advances Its Novel Cardiac Device to First-In-Human Trials for Mitral Valve Regurgitation
Date:1/26/2009

RESEARCH TRIANGLE PARK, N.C., Jan. 26 /PRNewswire/ -- Mardil Inc., a cardiac device company with novel technology for treating mitral valve regurgitation, has successfully advanced its device to first-in-human testing, a milestone achievement for the 2-year-old company.

The first patient was successfully implanted with the Mardil device last month in India. The patient had a significant improvement in heart function after the procedure, according to preliminary data from a 20-patient pilot study. Pending U.S. Food and Drug Administration approval of the clinical protocol, Mardil will launch a multinational clinical trial in the U.S., Canada, Israel, Australia and Europe in the fall of 2009.

"Mardil's concept is truly revolutionary in its approach in that the device simultaneously treats valvular dysfunction while supporting the weakened ventricular muscle, the latter of which is not being adequately addressed by the current therapies on the market," said Dr. Lishan Aklog, chief of cardiovascular surgery at St. Joseph's Hospital in Phoenix, Ariz.

Mitral regurgitation occurs when the mitral valve leaks blood backward into the heart, a condition that often leads to congestive heart failure and severe, debilitating symptoms. Current treatments for the condition, however, carry a range of serious complications and risks.

The average mortality rate for patients undergoing mitral valve repair and coronary artery bypass surgery together has risen to 10 percent, a statistic that Mardil founders hope to reduce with their device.

The Mardil device, called BACE(TM) (Basal Annuloplasty of the Cardia Externally), was pioneered by cardiothoracic surgeon Dr. Jai Raman in his efforts to develop a minimally invasive approach to treating mitral regurgitation.

"We designed BACE to reduce the significant costs, side effects and mortality rates associated with current mitral valve repair and replacement techniques," said Gopal Muppirala, chief executive officer and co-founder of Mardil. "Our device is minimally invasive in that it sits outside the heart and does not require open heart surgery or stopping the heart to implant the device."

BACE represents a departure from current devices because it addresses the root cause of the condition: a heart muscle that is weakened, stretched and enlarged, according to Raman, professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago.

"The Mardil device is the next-generation treatment for mitral valve regurgitation," said Raman. "BACE corrects the functional abnormality that leads to mitral regurgitation, whereas current devices on the market focus on replacing or repairing valves that are structurally normal."

In addition, the novel feature of BACE is that it can be remotely adjusted through ports under the skin that funnel saline to and from four inflatable chambers built into the tension band. The efficacy of BACE can be assessed at the time of implantation through a real-time echocardiogram, allowing for immediate adjustments in pressure.

The company is now finalizing its multinational clinical trial protocol for submission to the FDA this summer.

ABOUT MARDIL INC.

Mardil Inc. is a medical device company with a mission to design, develop and market innovative, patented cardiac technologies. Each technology will fulfill a current unmet need in cardiovascular medical procedures by improving upon an existing technology or by designing new technology that more effectively treats cardiovascular conditions. The company's first product is a minimally invasive device that treats functional mitral valve regurgitation. The device is currently in human trials.


'/>"/>
SOURCE Mardil Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
2. Pre-clinical Data on Recent Advances with HIV VLP Vaccine Presented at AIDS Vaccine 07 Conference
3. Avicena Scientific Collaborator Advances Program for Using Energy Enhancing Molecules to Treat Neuromuscular Diseases
4. Groundbreaking Study Proves Personalized Diet Based on Genetics Leads to Significant Advances in Long Term Weight Management and Blood Glucose Levels
5. Thermo Fisher Scientific Advances Gene-Silencing Technology for Life Sciences Research
6. Stem Cell Breakthrough Advances Science Without Ethical Landmines, Says Cardinal
7. Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs
8. MedImmune Advances Clinical Development of Antibody Targeting Interleukin-9 in Patients with Asthma
9. Transdel Pharmaceuticals Advances Lead Topical Pain Drug into Phase 3 Program
10. CuraGen Advances CR011-vcMMAE into Phase II
11. MedImmune Advances Asthma Program with Start of a Phase 2 Trial in Europe and Australia and First U.S.-Based Clinical Trial for Antibody Targeting IL-13
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... 2022" report to their offering. ... with kidney failure, it replaces the function of kidneys by ... and thus the treatment helps to keep the patient body,s ... Increasing number of ESRD patients & substantial healthcare ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
Breaking Medicine News(10 mins):