Navigation Links
Innovative Cardiovascular Solutions Announces Successful First Cases in European Clinical Study of EMBLOK Embolic Protection System
Date:3/15/2017

MILAN, March 15, 2017 /PRNewswire/ -- Innovative Cardiovascular Solutions (ICS), a privately held medical device company pioneering novel solutions for embolic protection during transcatheter aortic valve replacement (TAVR), announced today successful first European clinical cases using the EMBLOK™ Embolic Protection System in patients undergoing TAVR procedures. The cases were performed by Drs. Azeem Latib and Matteo Montorfano under the direction of Dr. Antonio Colombo at San Raffaele Hospital in Milan, Italy.

TAVR is indicated for use in intermediate, high, and extreme risk patients with severe aortic stenosis.  Its efficacy is currently being tested in low risk patients. However, numerous studies confirm that these procedures are associated with increased risk of neurological events as compared to conventional surgery, due to the embolic debris that enters the cerebral, abdominal and distal vasculature during the procedure. The EMBLOK system is the first circumferential aortic filter designed to fully capture and prevent embolic debris from reaching the brain and other vasculature during transcatheter valve procedures. 

"The EMBLOK system is intended to provide complete cerebral protection during valve implantation and is very easy to position, deploy and retrieve," said Dr. Latib. "It is the most intuitive filter I have ever used," added Dr. Montorfano.  Dr. Colombo further commented, "Of all the filters, this is the one I like the most, it is very straightforward to use."

The company's multi-center non-randomized feasibility study will evaluate subjects with severe native aortic valve stenosis who meet the commercially approved indications for TAVR. Study endpoints will include acute cerebral embolic burden and major adverse cardiac and cerebrovascular events (MACCE) at 30 days. 

"We're very encouraged the device exceeded physician expectations and performed well in the first clinical cases," said R. Kevin Plemmons, ICS's co-founder and CEO. "Interventional cardiologists and cardiovascular surgeons who perform left heart structural procedures demand the best care for their patients. We are pleased to meet this need with the first embolic system designed to offer both full collection and circumferential protection."

The EMBLOK system is currently available for investigational use only and is not approved for sale.

About the EMBLOK Embolic Protection System
The EMBLOK system is the world's first and only embolic protection device designed to offer full circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from embolic debris. In addition, the EMBLOK system incorporates an integrated 4 Fr radiopaque pigtail catheter which provides the physician constant visualization, while eliminating the need for constant dye injections to verify positioning. The entire system is 11 Fr and allows two devices (i.e., embolic filter and pigtail catheter) to be deployed through a single puncture site.

About Innovative Cardiovascular Solutions (ICS)
ICS strives to develop novel solutions that offer full capture and protection from embolic material released during left-sided heart procedures. With the first product, the EMBLOK Embolic Protection System, the goal is to improve patient quality of life and lower overall healthcare costs that are associated with embolic risks.

Media Contact
R. Kevin Plemmons
CEO, Innovative Cardiovascular Solutions
kevin@emblok.com

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/innovative-cardiovascular-solutions-announces-successful-first-cases-in-european-clinical-study-of-emblok-embolic-protection-system-300424272.html


'/>"/>
SOURCE Innovative Cardiovascular Solutions
Copyright©2017 PR Newswire.
All rights reserved


Related medicine technology :

1. Koning Corporation Receives New Innovative Technology Contract from Vizient, Inc. for Koning Breast CT
2. Innovative Veterinary Diagnostic Setting A New Standard
3. Pharmas Most Innovative Companies, the 2017 Ranking
4. 2017-2021 UK Hospital Hematology and Flow Cytometry Market Forecasts: Reagent and Instrument Supplier Shares, Competitive Strategies, Innovative Technologies, Instrumentation Review
5. Omnicell Launches Innovative Medication Adherence Automated Pharmacy Solution to Increase Pharmacy Efficiency and Profitability
6. Fast Company Honors Braeburn Pharmaceuticals as a Top Ten Most Innovative Company in Biotech
7. Alexander P. Hersel, M.D. and Bradley Spiegel, M.D., of Pain Management & Injury Relief Medical Center, achieve transformational results for back and leg pain with an innovative treatment
8. Marijuana Industrys Continued Growth Creating Innovative Cannabis-based Products and Services
9. Innovative Imaging and Surgery Used to Treat Lymph Condition in Adults
10. Soligenix Announces SGX942 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency
11. Gateway Health And Wellbridge Health Announce Partnership To Provide Healthcare Innovative Solutions to Gateway Membership
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)...  South Korean-based healthcare product Development Company I.M. Lab ... Kickstarter. The device will educate the user about ,proper, ... efficiency compared to the dated and pricey CPR training ... of the compression for a more informed CPR training. ... raise $5,000. cprCUBE ...
(Date:10/2/2017)...  Eli Lilly and Company (NYSE: LLY ... quarter of 2017 on Tuesday, October 24, 2017. Lilly ... with the investment community and media to further detail ... will begin at 9 a.m. Eastern time. Investors, media ... of the conference call through a link that will ...
(Date:9/28/2017)... Sept. 28, 2017 Hill-Rom Holdings, Inc. (NYSE: ... conference call and webcast on Friday, November 3, 2017, ... and ending at approximately 8:30 a.m. (CDT) / 9:30 ... company,s 2017 financial performance and guidance for 2018, Hill-Rom ... to enhance operational performance, and long-range financial outlook through ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... ProVest Insurance Group, a family managed ... Raleigh regions, is organizing an extended charity drive to benefit the family of ... , After struggling since birth with several health challenges, T.J. was later diagnosed ...
(Date:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... ... 13, 2017 , ... Many families have long-term insurance that covers care for ... a waiver for care if the client has a cognitive impairment diagnosis. , ... care, is often waived, so the benefits from their insurance start immediately,” said Mechell ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... viewers the lowdown on sciatica in a new episode of "Success Files," which ... current events and innovation and investigates each subject in-depth with passion and integrity. ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
Breaking Medicine News(10 mins):