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NOTICIAS


24 octubre 2012

Direct Flow Medical Transcatheter Aortic Valve System meets primary endpoint in DISCOVER trial

Cardiovascular NEWS

Results from the DISCOVER CE mark trial have shown that the Direct Flow Medical Transcatheter Aortic Valve System met its primary mortality endpoint. The study also demonstrated that greater than 95% of patients had mild or less aortic regurgitation, and no patients experienced vascular complications. Data were presented by co-principal investigator Joachim Schofer, Medical Care Center, Hamburg, Germany, at the TCT congress.

24 octubre 2012

BioMatrix Flex improves clinical outcomes compared to Cypher Select for up to five years, LEADERS trial shows

Cardiovascular NEWS

Five-year results from the LEADERS trial have shown improved long-term clinical outcomes for BioMatrix Flex Biolimus A9-eluting stent system (Biosensors) compared to Cypher Select sirolimus-eluting stent system (Johnson & Johnson). BioMatrix Flex significantly reduced the risk of clinical events compared with Cypher Select, which was associated with a reduced risk of very late stent thrombosis (VLST).

24 octubre 2012

Parachute device gets CE mark for full range of sizes

Cardiovascular NEWS

CardioKinetix has received CE mark approval for the full size matrix of its Parachute Ventricular Partitioning Device for percutaneous ventricular restoration (PVR) therapy.

24 octubre 2012

Volcano Corporation Announces Global Launch of PrimeWire Prestige® PLUS Pressure Guide Wire with AcuSense™ Technology

Bio Space

SAN DIEGO, Oct. 23, 2012 /PRNewswire/ -- Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced the global launch of the PrimeWire Prestige® PLUS pressure guide wire with AcuSense technology, which allows for more precise measurements when distal pressure is monitored for longer periods of time. The new offering is the fourth new pressure guide wire from Volcano in four years and will serve as the platform for Volcano s expanding clinical programs. The PrimeWire Prestige PLUS product will be used in six newly announced Volcano-sponsored clinical studies to explore new indications in stable and unstable CAD, peripheral arterial disease and neurology.

23 octubre 2012

FDA approves Gore Septal Occluder for use in Gore REDUCE clinical study

Cardiovascular NEWS

The US Food and Drug Administration (FDA) has approved the use of the new Gore septal occluder for inclusion in the Gore REDUCE clinical study. Gore is introducing the technology in the REDUCE study for prevention of recurrent stroke in patent foramen ovale (PFO) patients.

23 octubre 2012

ADVANCE study results show high survival rates and improved quality of life for patients using the CoreValve system

Cardiovascular NEWS

The ADVANCE study findings were presented this week at Transcatheter Cardiovascular Therapeutics (TCT) Meeting 2012 (Miami, USA, 22–27 October). Initial one year results of the study revealed that patients experienced high survival rates, with one year survival at 82.1% and one year cardiovascular survival at 88.2% Health-related quality of life (HRQoL) measured for patients in the study had improved significantly at one and six months, compared with their status prior to receiving the Medtronic CoreValve System. The study represents the largest, most rigorously collected evaluation of HRQoL findings published on transcatheter aortic valve implantation (TAVI). The CoreValve System is currently limited to investigational use in the United States.

23 octubre 2012

Zotarolimus-eluting stent successfully treats long lesions and small vessels in multiple studies

Cardiovascular NEWS

For the treatment of long lesions and small vessels – two challenging characteristics of coronary artery disease commonly found in patients with diabetes – the Resolute zotarolimus drug-eluting stent from Medtronic delivered successful clinical results, according to new data presented at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

23 octubre 2012

Svelte announces FDA approval to initiate a pivotal study of its coronary stent Integrated Delivery System

Cardiovascular NEWS

On 22 October 2012, Svelte Medical Systems announced it received conditional approval from the FDA to begin a pivotal study for the Svelte coronary stent Integrated Delivery System (IDS). Approved by the FDA under an investigational device exemption (IDE), the study will evaluate the safety and effectiveness of the Svelte IDS in approximately 370 patients at up to 30 investigative sites in the USA.

23 octubre 2012

Cost-effectiveness study determines FFR can improve health while reducing economic burden in the UK

Cardiovascular NEWS

St Jude Medical has announced that an analysis of the benefits to using a fractional flow reserve (FFR)-guided intervention strategy found that the technology can improve patient outcomes while saving significant amounts of money. The analysis, which was funded by an educational research grant from St Jude Medical, found that within each of the country’s respective health care systems, the FFR-guided approach is cost-saving, meaning that use of FFR improves health outcomes for patients with multivessel coronary artery disease at lower costs when compared to using angiography alone.

22 octubre 2012

Cappella Medical announces positive long term follow-up results for its Sideguard Technology at TCT 2012

Cardiovascular NEWS

Cappella has announced the multicentre long term follow-up results for its Sideguard coronary side branch stent. Long term follow-up data on the stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 day follow-up), 7.1% (six months follow-up) and 10.2% (one year follow-up) comparing favourably with existing standard practice.

22 octubre 2012

FDA expands use of Sapien artificial heart valve

Cardiovascular NEWS

On 19 October, the US Food and Drug Administration (FDA) expanded the approved transcatheter aortic valve implantation (TAVI) indication for the Sapien Transcatheter Heart Valve (Edwards Lifesciences) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.

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