Country for PR: United States
Contributor: PR Newswire New York
Monday, July 01 2019 - 21:10
AsiaNet
Cardiac Dimensions Reaches 1,000 Implants Of Carillon(R) System, A Minimally Invasive Treatment For Functional Mitral Regurgitation
KIRKLAND, Washington, July 1, 2019 /PRNewswire-AsiaNet/ --

Cardiac Dimensions (R) ( 
https://c212.net/c/link/?t=0&l=en&o=2511123-1&h=3942458282&u=https%3A%2F%2Fcardiacdimensions.com%2F&a=Cardiac+Dimensions 
), a leader in the development of innovative, minimally invasive treatments for 
functional mitral regurgitation (FMR) in patients with heart failure, today 
announced the Carillon Mitral Contour System(R) has been implanted in 1,000 
patients in the United States, Europe, Australia, Turkey and the Middle East. 
The Carillon System is a right-heart transcatheter mitral valve repair (TMVr) 
device designed to treat the primary cause of FMR in patients with MR grades 
2+, 3+ and 4+.

Photo - 
https://mma.prnewswire.com/media/444446/Cardiac_Dimensions_Carillon_System.jpg

Logo - https://mma.prnewswire.com/media/444443/Cardiac_Dimensions_Logo.jpg

“We are proud to be part of this momentous occasion, having treated the 1,000th 
patient with the Carillon System, in a live case during CSI Frankfurt 2019 ( 
https://www.csi-congress.org/conferences-courses/conferences/frankfurt ), where 
a large, international audience was able to gain an appreciation for this 
technology’s unique value and versatility,” stated Horst Sievert, MD, Director 
and Founder of the Cardiovascular Center Frankfurt in Frankfurt, Germany. “The 
ability to offer patients an early-intervention, non-surgical treatment for 
mitral regurgitation, while preserving future treatment options is of enormous 
benefit to my patients suffering from heart failure.”

"This is a highly anticipated milestone for our company as we witness the 
1,000th implantation of the Carillon System," said Gregory D. Casciaro, 
President and CEO of Cardiac Dimensions. "It was not long ago that surgical 
intervention was the final solution to treating FMR. We are now part of a new 
paradigm of minimally invasive care that can safely and effectively treat FMR 
in a wide range of patients. Because the Carillon System preserves mitral valve 
leaflet integrity, patients can be treated earlier in the highly progressive 
disease cycle."

The company's announcement of the 1,000th implant of the Carillon System 
precedes the highly anticipated publication of the positive 1-year results of 
its blinded, multicenter, randomized controlled trial, REDUCE FMR ( 
https://c212.net/c/link/?t=0&l=en&o=2511123-1&h=4029601766&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02325830%3Fcond%3Dreduce%2BFMR%26rank%3D1&a=REDUCE+FMR 
), which are expected to be released in the July 2019 edition of the Journal of 
American College of Cardiology: Heart Failure. The early data, which was 
presented at a late-breaking trial session ( 
https://c212.net/c/link/?t=0&l=en&o=2511123-1&h=3768437031&u=https%3A%2F%2Fwww.tctmd.com%2Fnews%2Freduce-fmr-percutaneous-annuloplasty-reduces-regurgitation-heart-failure-patients-functional&a=late-breaking+trial+session 
) at last year's Transcatheter Cardiovascular Therapeutics (TCT) conference,1 
complements the growing body of evidence demonstrating the consistent and 
durable effectiveness and safety of the Carillon System. 

"This is an exciting time for me and the entire team," stated Rick Wypych, 
Chief Financial Officer and Chief Operating Officer and a long-time employee of 
the Company. "We are honored and proud to be part of this important journey to 
develop a first-line therapy in the treatment of FMR."  Wypych continues, "2019 
is shaping up to be a momentous year for Cardiac Dimensions with new positive 
data presented at the DGK and TVT conferences, FDA approval of the updated 
CARILLON clinical trial protocol, and implementation of the German DRG 
reimbursement code. We are thrilled to have patients continue to benefit from 
this landmark technology."

About the Carillon Mitral Contour System 
The Carillon System offers a simple right heart approach to transcatheter 
mitral valve repair (TMVr) designed to reshape the anatomy and function of the 
mitral apparatus from the coronary sinus. Distal and proximal anchors, 
connected by a shaping ribbon, utilize the heart's venous anatomy to cinch the 
mitral apparatus without compromising the valve or future treatment 
options.[2,3]  The Carillon System is designed to treat the primary cause of 
functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ 
and is the first and only device to demonstrate a reduction in regurgitant 
volume and favorable left ventricular remodeling in a blinded, randomized, 
sham-controlled clinical trial of percutaneous valve therapy.[1] 

The Carillon System is CE-marked (0344) and has been implanted in 1000 patients 
in Europe, Australia, Turkey and the Middle East. The Carillon System is 
approved for investigational use in the United States.

About Cardiac Dimensions, Inc. 
Cardiac Dimensions is a leader in the development of innovative, minimally 
invasive treatments to address heart failure and related cardiovascular 
conditions. Privately held, the company is funded by Aperture Venture Partners, 
Arboretum Ventures, Difference Capital, HostPlus, Life Sciences Partners, 
Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in 
Kirkland, Washington and has operations in the United States, Australia and 
Germany. For more information, visit www.cardiacdimensions.com.

MEDIA CONTACT: 
Rick Wypych 
rwypych@cardiacdimensions.com 
+1 (425) 605-5910

1. Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of 
Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with 
Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA. 
2. Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device 
leaves free access to cardiac veins for resynchronization therapy. Catheter 
Cardiovasc Interv. 2009;74(3):506-11. 
3. Latib, A. "Coronary Sinus Annuloplasty." New York, Montefiore Medical 
Center. Miami Valves Conference. February 2019

SOURCE: Cardiac Dimensions, Inc.