Volcano Corp. (VOLC)s test that shows which patients need heart stents could lead to a $2 billion market within a decade as more doctors use it to improve care, Chief Executive Officer Scott Huennekens said.
ABBOTT PARK, Ill., Jan. 8, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) announced today the initiation of the ABSORB III clinical trial in patients in the United States. This randomized, controlled trial is designed to enroll approximately 2,250 patients, the majority in the United States, and compare the performance of Abbott s drug eluting Absorb Bioresorbable Vascular Scaffold (BVS) device to the company s XIENCE family of drug eluting stents. The start of this trial in the United States follows the recent international commercial launch of Absorb in Europe and parts of Latin America and Asia, including the recent regulatory approval and launch in India a country with a significant and growing prevalence of heart disease. Data from the ABSORB III trial will support U.S. regulatory filings for Absorb.
Randomized Multicenter PARACHUTE IV Clinical Trial Will Compare Minimally Invasive Device to Optimal Medical Therapy MENLO PARK, Calif.--(BUSINESS WIRE)--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute™ Ventricular Partitioning Device for the treatment of heart failure.
Tryton Medical has pulled in $24 million in equity financing, looping all its investors to pitch in as it prepares to seek FDA approval for its Side Branch Stent to treat bifurcated lesions.
ABBOTT PARK, Ill., Jan. 3, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the XIENCE Xpedition Everolimus Eluting Coronary Stent System received U.S. Food and Drug Administration (FDA) approval and is launching immediately in the United States, providing physicians with a next-generation technology with the largest size matrix in the U.S. market. XIENCE Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies.
Abbott ($ABT) is pursuing an immediate U.S. rollout of its next-generation Xience Xpedition drug eluting stent, backed by a long-awaited FDA approval announced Jan. 3. Four months ago, the product gained a CE mark in Europe.
Abbott has announced that its Xience Xpedition everolimus eluting coronary stent system has received US FDA approval and that it is immediately launching the system onto the USA market
NeoChord has announced that it has received the CE mark for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a transapical, off-pump procedure
NEW YORK, Jan. 2, 2013 /PRNewswire/ -- AbbVie (NYSE:ABBV) today marks its launch as an independent biopharmaceutical company, with employees from more than 40 countries and patients joining AbbVie leaders as they ring the first opening bell of 2013 at the New York Stock Exchange.
Biotronik announced that the first implant has taken place in the BIOHELIX-I trial in the United States. The BIOHELIX–I trial is set to evaluate the safety and performance of the PRO-Kinetic Energy coronary, bare metal stent. The first implant was successfully performed by H Barrett Cheek, of Carolina Cardiology Cornerstone, High Point Regional Hospital, High Point, North Carolina.
On 20 December 2012, Svelte Medical Systems announced treatment of the first patient in the ACES (Acrobat coronary stent system effectiveness European study) clinical trial by Victor Legrand, at CHU Liege in Liege, Belgium. ACES is a randomised, controlled study designed to demonstrate the positive clinical benefit and impact on resource utilisation of the Svelte Acrobat Integrated Delivery System (IDS) compared with conventional coronary stent devices in patients with lesions eligible for direct stenting. Up to 300 patients will be enrolled in the study at 12 sites in France, Belgium and Spain.
St Jude Medical announced on 18 December 2012 the first patient enrolment in its ILUMIEN I clinical study. This observational study is designed to show the optimal way optical coherence tomography (OCT), combined with the St Jude Medical PressureWire Aeris, a wireless interventional tool that measures fractional flow reserve (FFR), can guide stent implantation in patients with coronary artery disease.
Hiroki Mizoguchi, Division of Cardiology, National Hospital Organization Okayama Medical Center, Okayama, Japan, and colleagues have refined balloon pulmonary angioplasty for the treatment of inoperable patients with chronic thromboemobolic pulmonary hypertension (CTEPH).
Colibri Heart Valve, LLC has announced that it has successfully completed the first clinical use of the company’s proprietary transcatheter aortic heart valve. The Colibri transcatheter aortic valve implantation (TAVI) system is the world’s first and only low profile, 14 French pre-mounted, pre-crimped, and pre-packaged, ready-for-use, TAVI system.
By Cosmo Godino. Coronary chronic total occlusions (CTOs) remain a technical challenge and an unresolved clinical dilemma, even after numerous successes and rapid progression in the field of interventional cardiology. As shown by registry-based studies, the rationale behind CTO revascularisation is that of it provides improved survival and quality of life. However, until now there is no evidence regarding which category of patients benefit most from CTO revascularisation and conversely, which subgroups of not revascularised patients are at highest risk of future cardiac events. Moreover, the lack of a true randomised controlled trial with a medically treated control group raises the question of whether the survival benefit demonstrated with successful percutaneous coronary intervention (PCI) is, in fact, related to beneficial effects of opening a chronically occluded vessel versus potential harm conferred to those with CTO-PCI failed.
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