Navigation Links
ATS Medical Provides Update on Clinical Progress of ATS 3f Enable Aortic Bioprosthesis
Date:11/28/2007

MINNEAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- ATS Medical Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced that a total of 47 patients have now undergone aortic valve replacement with its sutureless ATS 3f Enable(TM) Aortic Bioprosthesis at seven investigative sites in Europe within both the feasibility and pivotal clinical trial phases. Currently, eight patients have surpassed the two year implant duration.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO)

The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate the traditional suturing required to replace a patient's diseased aortic heart valve. If suturing can be eliminated from the procedure, surgeons can potentially reduce procedure time and offer less invasive options for the treatment of aortic valve disease. In addition, the elimination of suturing offers the potential to significantly improve valve related hemodynamics by allowing the surgeon to provide a replacement valve of a size larger than what is traditionally possible with conventionally sutured heart valves.

The most recent phase of the clinical trial was designed to evaluate the effectiveness of the ATS 3f Enable Aortic Bioprostheses "sutureless" solution with respect to hemodynamics, avoiding peri-valvular leakage, and valve migration post surgery. After more than 25 consecutive procedures within the pivotal trial phase utilizing an updated pivotal trial protocol, the ENABLE 'sutureless' solution has provided excellent clinical outcomes for peri-valvular leak comparable to conventional surgery. It has been further established that valve migration has not been a risk with the ENABLE heart valve.

Prof. Thierry P. Carrel of the University Hospital of Bern, Switzerland stated, "We are very encouraged by our ATS 3f Enable heart valve experience. The unique sutureless implantation feature of the ENABLE valve provides several important clinical benefits for our patients. Notably, because the valve requires no sutures to implant we are able to put in a larger valve than would otherwise be possible using a conventionally sutured heart valve. As a result, the hemodynamic performance observed is truly outstanding. And unlike with sutureless percutaneous valves, there has been no trade off or compromise in clinical performance. Specifically, we have not observed any peri-valvular leaks or migration with the ENABLE prosthesis. Prof. Friedrich S. Eckstein, also of the University Hospital of Bern, added, "The ENABLE sutureless implant procedure is remarkably simple. Because we are able to eliminate the suturing and much of the time that normally accompanies aortic valve replacement, we have been able to provide more of our patients a less invasive procedure using smaller incisions without compromising clinical outcome."

ATS Medical Inc. President and CEO, Michael Dale said, "We are very pleased with the results from our updated pivotal protocol. The potential benefits of a sutureless aortic heart valve are many, but up until the introduction of the ENABLE heart valve, 'sutureless' designs could not claim equality with conventional surgery outcomes. This was particularly true with regard to peri-valvular leakage. For less invasive aortic valve surgery to move forward as a standard of care, clinical outcomes must be at least equivalent to conventional surgical technique. We believe these results for ENABLE demonstrate this is possible. Our intellectual property in this area is comprehensive and we believe our design is practical and with this milestone we look forward to expanding our enrollment in this exciting clinical trial."

Prof. Sven Martens, MD, PhD, of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany said, "The ATS 3f Enable Aortic Bioprosthesis has been chosen by us because of the excellent hemodynamics, especially in patients with a small aortic annulus. The early results are very promising and while more time is needed, we believe that for these patients, this device may truly advance the standard of care for aortic valve surgery."

The ATS 3f Enable Aortic Bioprosthesis is the second product stemming from the ATS 3f(R) Aortic Bioprosthesis platform. Utilizing the same valve leaflet design and materials, the company has been able to preserve excellent product performance and durability. ATS has now expanded into the sutureless implant procedure and will utilize these base products and technologies to further advance the standard of heart valve repair and replacement. ATS' strategy has been to develop and provide an excellent Aortic Bioprosthesis, to utilize this platform to improve standard aortic valve replacement surgery through sutureless products and procedures, and then to provide products and procedures to allow for minimally invasive heart valve repair and replacement in a safe and effective manner. The company will proceed with an expanded clinical evaluation at a select number of international sites as we proceed through the regulatory process for US IDE and International CE Mark approvals.

About ATS Medical

ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, is headquartered in Minneapolis, Minnesota. More than 140,000 ATS Open Pivot(R) Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide. The ATS 3f(R) brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology. ATS Medical's focus on serving the cardiac surgery community is further strengthened by offerings that include ATS Simulus(R) annuloplasty products for heart valve repair, ATS CryoMaze(TM) surgical ablation products, and RTI-Cardiovascular for allograft tissue services. The ATS Medical web site is http://www.atsmedical.com.

Safe Harbor

This Press Release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. Actual results could differ materially from those projected in the forward looking statements as a result of a number of important factors, including the results of clinical trials, the timing of regulatory approvals, the integration of 3f Therapeutics and the surgical cryoablation business of CryoCath Technologies, Inc., regulatory actions, competition, pricing pressures, supplier actions and management of growth. For a discussion of these and other risks and uncertainties that could affect the Company's activities and results, please refer to the Company's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2006 and its most recent quarterly report on Form 10-Q.


'/>"/>
SOURCE ATS Medical Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. MSU engineering team designs innovative medical device
2. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
3. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
4. Owner and Operator of Florida Durable Medical Equipment Company Convicted of Medicare Fraud
5. Father and Daughter From Tanzania Receive Their First Medical Examination in Newport Beach
6. Doctors and medical ethicist discuss whether doctors should participate in capital punishment
7. Preparation for Natural Disasters Critical for People With Diabetes, Chronic Medical Conditions
8. Doctors and Medical Ethicist Discuss Whether Doctors Should Participate in Capital Punishment
9. Symmetry Medical Completes Acquisition Of Specialty Surgical Instruments
10. Milestone Scientific Announces Successful Completion of its Collaboration Agreement With Carticept Medical
11. Sontra Medical Corporation Changes Name to Echo Therapeutics, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... California (PRWEB) , ... June 27, 2016 , ... "FCPX ... fully customizable inside of Final Cut Pro X," said Christina Austin - CEO of ... unique style. Final Cut Pro X users can now reveal the media ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: ... novel therapeutics for the treatment of grievous blood-based ... closing of its previously announced underwritten public offering ... public offering price of $18.75 per share. All ... by GBT. GBT estimates net proceeds from the ...
(Date:6/24/2016)... Dublin ... of the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global ... including its applications in various applications. The report deals ... three main industries: pharmaceutical and biotechnology, food and beverage, ...
(Date:6/24/2016)... 24, 2016 The Academy of Managed Care ... that would allow biopharmaceutical companies to more easily ... make formulary and coverage decisions, a move that addresses ... medicines. The recommendations address restrictions in the ... the drug label, a prohibition that hinders decision makers ...
Breaking Medicine Technology: