February 20, 2012 — Edwards Lifesciences Corp. announced that it received CE mark in Europe for its Edwards Intuity valve system for use in patients undergoing surgical aortic valve replacement (...
February 16, 2012 — Siemens Healthcare received clearance from the U.S. Food and Drug Administration (FDA) for syngo Aortic ValveGuide, an integrated image processing software that helps...
February 3, 2012 — Colibri Heart Valve received an notification it received patents for a new transcatheter heart valve from the United States Patent and Trademark Office.
February 3, 2012 — Medtronic Inc. issued a statement on the results of two studies evaluating the use of the Medtronic CoreValve system delivered through the direct aortic implantation approach....
January 30, 2012 — Medtronic, Inc. announced the completion of patient enrollment in the extreme risk study in its CoreValve United States Pivotal Trial. The company received approval from the U.S...
The 2012 American College of Cardiology (ACC) meeting in Chicago, March 24-26, includes five sessions of late-breaking trials. The ACC announced the following trials will be included:
January 26, 2012 — Heart Hospital of Austin opened a heart valve clinic, the first of its kind in the region. The clinic gives new hope to patients with severe aortic stenosis who were previously...
January 17, 2012 – Terumo Americas Holding Inc., a U.S. subsidiary of Japan's Terumo Corp., announced it acquired Onset Medical Corp., which develops interventional procedural access sheath...
January 4, 2012 – ECRI, an independent nonprofit that researches the best approaches to improving patient care, listed 10 health technology issues that hospital leaders should have on their watch...
December 28, 2011 – Edwards Lifesciences announced two-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards Sapien transcatheter...
December 23, 2011 - Philips Healthcare said Medical City Dallas Hospital, Dallas, Texas, is the first hospital in the United States to use Philips’ HeartNavigator interventional tool in clinical...
Each year I attend Transcatheter Cardiovascular Therapeutics (TCT), I comb the event and its sessions looking for the next big trend or technological innovations in cardiovascular devices. Below...
November 15, 2011 — A two-year study of patients in the landmark PARTNER trial confirms the one-year findings and supports transcatheter aortic valve replacement (TAVR) as the standard-of-care.
November 15, 2011 – Results of the PARTNER Cohort A QOL study demonstrate that transcatheter aortic valve replacement (TAVR) results in improved quality of life compared with surgical valve...
November 14, 2011 — Edwards Lifesciences Corp. announced data were presented on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) were presented at...
November 10, 2011 — The results of an analysis of 149 EVEREST II high surgical risk patients with significant mitral regurgitation (MR) of functional etiology were presented at Transcatheter...
November 10, 2011 — Edwards Lifesciences Corp. announced the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to the PARTNER II Trial. The...
Medtronic today announced it received CE (Conformité Européenne) mark for the CoreValve System to be delivered using direct aortic access. The Medtronic CoreValve System is now the only...
November 7, 2011 – Abbott announced the company's schedule of key data presentations at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, to be held Nov. 7 – 11...
November 3, 2011 – Medtronic announced the first implant in a clinical trial in Japan that will evaluate the safety and effectiveness of the Medtronic CoreValve System...
The U.S. Food and Drug Administration (FDA) today approved the first transcatheter aortic heart valve in the United States - the Sapien THV. Experts say the approval will open a new chapter in how...
November 1, 2011 – Claret Medical Inc. said its Montage System has received CE mark approval as the world's first complete system of filtration to protect both carotid arteries simultaneously. The...
November 1, 2011 – Boston Scientific released the schedule of its major events and product-related clinical research for the Cardiovascular Research Foundation's (CRF) 23rd annual Transcatheter...
In a closely watched move viewed as a big step toward a paradigm shift in how heart valves are repaired in the United States, a U.S. Food and Drug Administration (FDA) advisory panel voted late...
October 7, 2011 – ValveXchange Inc., has performed successful first-in-man (FIM) surgeries demonstrating the practicality and advantages of its novel Vitality two-part heart valve system. Two...
October 3, 2011 — JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation (TAVI) systems, announced it has received CE...
October 3, 2011 – Cardiac Dimensions Inc. announced it received European CE mark approval for a newly enhanced version of its Carillon Mitral Contour System, a therapy for treating heart failure...
September 15, 2011 – The Cardiovascular Research Foundation (CRF) has announced the late breaking trials and first report investigations that will be presented at the Transcatheter Cardiovascular...
September 12, 2011 — Cardiovascular market research firm Zacks Equity Research released a new report discussing high growth areas in medical devices, including Medtronic Inc., Boston Scientific...
August 30, 2011 – Results from a study presented at the European Society of Cardiology (ESC) Congress 2011 show that transcatheter aortic-valve implantation (TAVI) in low-risk patients met...
August 30, 2011 – Single center data of the German Heart Centre in Munich demonstrate a sustained improvement of hemodynamic values up to three years after CoreValve implantation. There are no...
August 29, 2011 — An observational study demonstrates the percutaneous catheter-based MitraClip treatment improves symptoms and promotes reverse left ventricular (LV) remodeling in patients with...
August 19, 2011 - Neovasc Inc. accomplished $4.7 million in financing to complete the COSIRA clinical trial for the Neovasc Reducer to treat refractory angina. The company will also advance the...
August 8, 2011 – Edwards Lifesciences announced the global launch of the Carpentier-Edwards Physio Tricuspid Annuloplasty Ring for the treatment of tricuspid valve insufficiency. The company...
If approved by the U.S. Food and Drug Administration (FDA) later this summer, transcatheter valve therapy (TVT) – an innovative procedure that uses minimally invasive catheter-based technology to...
June 21, 2011 – The Heart Hospital of Austin, a physician-led hospital specializing in the diagnosis and treatment of cardiovascular disease in Austin, Texas, recently adopted the Philips iE33...
June 21, 2011 – The St. Francis Heart Center in Indianapolis, Ind., announced that it has performed the first post-U.S. Food and Drug Administration (FDA) approval surgery in the United States using...
June 10, 2011 - A U.S. Food and Drug Administration (FDA) advisory panel is scheduled to review Edwards Lifesciences’ premarket approval (PMA) application for the Sapien transcatheter heart valve on...
May 23, 2011 - A presentation about transcatheter aortic valve implantation (TAVI) at EuroPCR 2011 confirmed positive outcomes in patients receiving the CoreValve System from Medtronic Inc., across...
May 20, 2011 - Edwards Lifesciences Corporation announced that clinicians continued to achieve successful one-year outcomes in high-risk or inoperable patients undergoing transcatheter aortic valve...
May 19, 2011 – New clinical data presented today at EuroPCR 2011 demonstrate immediate and long-term health-related quality-of-life (HRQoL) benefits for patients receiving the Medtronic CoreValve...
May 9, 2011 — John Webb, M.D., FSCAI, has traveled the globe teaching fellow physicians how to repair or replace faulty heart valves using minimally invasive techniques. In a keynote Founders’...
May 4, 2011 -- Two new clinical studies will use the Carillon Mitral Contour System, an investigational device for percutaneous treatment of functional mitral regurgitation (FMR).
April 22, 2011 – The U.S. Food and Drug Administration (FDA) has cleared the Trifecta valve, by St. Jude Medical. The valve, a clinically-proven replacement for diseased, damaged or malfunctioning...
April 11, 2011 — The following is a roundup of key news and trial data that came out of the American College of Cardiology (ACC) 2011 Scientific Session in New Orleans last week. ...
The transcatheter MitraClip mitral valve repair system continues to compare favorably with conventional open-heart surgery for treatment of select patients with mitral regurgitation. The findings...
April 6, 2011 – Data from the EVEREST II study show that patients with significant mitral regurgitation (MR) continue to show benefits from treatment with a catheter-based valve-clip system at one...
April 6, 2011 – Development of a novel embolic protection device designed for use during transcatheter aortic valve implantation (TAVI) procedures received $10.5 million in funding. SMT Research...
April 5, 2011 – Death rates are similar at one year for a catheter-based aortic valve replacement procedure and conventional surgery in older high-risk patients.
April 4, 2011 – A new system for treating mitral regurgitation (MR) has been launched in Australia. The MitraClip device, by Abbott, has received Therapeutic Goods Administration (TGA) approval...
March 29, 2011 – One-year outcomes from Cohort A of the PARTNER trial will be presented April 3 at the American College of Cardiology’s (ACC) 60th Annual Scientific Session and Expo in New Orleans...
March 15, 2011 – A new tricuspid ring for the treatment of tricuspid valve disease is approved for use in the United States, Europe and several other countries. The Contour 3D Annuloplasty Ring,...
March 14, 2011 – Expanding its transcatheter valve accessories with the addition of an aortic embolic protection device, Edwards Lifesciences Corp. completed the acquisition of Embrella...
March 1, 2011 – A bioprosthetic heart valve has demonstrated positive performance at 12 years, according to a study published in The Journal of Thoracic and Cardiovascular Surgery....
February 25, 2011 – A larger transcatheter aortic heart valve has received the CE mark. The 29 mm version of the Sapien XT valve, from Edwards Lifesciences, promises to expand the number of...
February 18, 2011 – An independent study in the journal Circulation confirmed the early and sustained clinical benefits for a system treating aortic valve disease.
February 9, 2011 – The U.S. District Court for the District of Delaware reaffirmed an April 2010 federal jury decision that determined Medtronic CoreValve LLC willfully infringed Edwards...
February 1, 2011 – A self-anchoring aortic heart valve has received the CE mark. With the approval, the Perceval S Sutureless biological valve, by the Sorin Group, is now commercially available in...
January 31, 2011 – The first successful transcatheter implantation of a 27 mm transapical aortic valve prosthesis has been completed. The procedure was performed by Hendrik Treede, M.D., at the...
January 19, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional approval to modify the CoreValve U.S. pivotal clinical trial to eliminate the medical management arm of the study...
December 29, 2010 - Research on reducing risks, improving medical treatment and improving lifestyle behaviors to fight the battle against heart disease and stroke are among the key scientific...
December 10, 2010 – European CE mark approval has been granted so the Medtronic CoreValve transcatheter aortic valve replacement system can be delivered through the subclavian artery, located...
November 23, 2010 – Boston Scientific will acquire Sadra Medical, a development-stage company in Los Gatos, Calif. Boston Scientific will pay $193 million up front, plus potential payments of up...
November 16, 2010 – Analysis of data from the PARTNER trial showed that patients implanted with transcatheter heart valve not only experienced improved survival, but also substantially better...
November 3, 2010 – A multicenter CE-mark study has been launched for transapical TAVI system. Hendrik Treede, M.D., performed the first implantations of the system, made by JenaValve, at the...
October 15, 2010 – An investigational trial of Medtronic’s CoreValve transcatheter aortic valve has been approved by the U.S. Food and Drug Administration (FDA) today. The investigational device...
October 5, 2010 – Edwards Lifesciences has opened a new 300,000-square-foot facility in Draper, Utah, allowing the company to significantly expand its manufacturing and development capabilities,...
September 29, 2010 – Physicians from the Cedars-Sinai Heart Institute will lead a clinical trial evaluating transcatheter aortic valve implantation (TAVI) for patients who experience severe aortic...
Transcatheter valve therapies were among the hottest topics at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) symposium and the key presentation was the very positive first release of...
