Medtronic Presents One-Year Data on Endurant(R) Stent Graft

The Endurant(R) Stent Graft System used for abdominal aortic aneurysms, from Medtronic, Inc., delivered strong results through one year of patient follow-up in the company's U.S. pivotal study, according to clinical data presented at VEITHsymposium(TM).

Approved by the U.S. Food and Drug Administration (FDA) under an investigational device exemption (IDE), the prospective study involved 150 patients at 26 U.S. medical centers and met its primary endpoints. In the study, the Endurant System was associated with no post-operative aneurysm ruptures or aneurysm-related mor...talities at one year, and there were no mortalities from any cause at 30 days.

It received the CE (Conformite Europeene) mark in July 2008.

 

Fw: Invatec received clearance from...

Invatec received clearance from FDA in October to market its Mo.Ma Ultra Proximal Cerebral Protection Device for use during carotid artery stenting (CAS).-SICT
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Medtronic's Resolute Drug-Eluting Stent Shows Strong Performance in Second 'All Comers' Study

New clinical data from a second, large international study that enrolled "all comers," regardless of disease complexity and comorbidities, again demonstrated the strong performance of the Resolute drug-eluting stent (DES) from Medtronic,


The findings include one-year results for RESOLUTE International, two subsets from RESOLUTE All Comers, and four-year results for the RESOLUTE feasibility study, which supported the CE (Conformite Europeenne) mark of the Resolute DES.

Promising New Therapy for Drug-Resistant Hypertension

The therapy pioneered by Mercator MedSystems, Inc., combines the use of the company's Bullfrog® Micro-Infusion Catheter with a known drug to reduce the hyperactivity of nerves in the renal artery leading to and from the kidney. These nerves are implicated in the initiation and maintenance of high blood pressure. he early data shows that this therapy precisely targets these nerves, achieving the desired effect without negatively affecting surrounding tissue.


The slender Micro-Infusion Catheter is introduced into an artery through a small needle in the upper leg, and is guided into the main kidney artery (the renal artery). Once positioned, a balloon at the tip of the catheter is inflated inside the artery, sliding a 130 micron (two hair widths thick) microneedle through the artery wall into the tissue known as the adventitia, which envelops the hyperactive nerves leading to the kidney. As the drug is infused through the microneedle, it surrounds the artery to create an effective cylindrical treatment zone and reduces the nerve signals which cause high blood pressure.

http://www.MercatorMed.com

Neovasc Reducer(TM) for Refractory Angina Featured in Live Case Sessi on at TCT 2010 Conference

The Neovasc Reducer is a novel device designed to treat patients who
suffer from refractory angina, a painful and debilitating condition that
occurs when the coronary arteries deliver an inadequate supply of blood
to the heart muscle. Refractory angina currently affects over two
million patients worldwide, who typically lead severely restricted
lives.

 

Link:

www.neovasc.com

Results from Three Peripheral Clinical Studies at TCT on September 22

Cardiovascular Systems Inc., announced today that its CALCIUM 360 deg Study, the first-of-its kind prospective, randomized feasibility study, demonstrated the safety and effectiveness of plaque modification with the Diamondback 360(R) PAD System versus the standard of care treatment (balloon angioplasty) in below-the-knee arteries. This study contributes to a large and growing body of clinical evidence from 1,200 patients in nine clinical trials demonstrating that the Diamondback 360 deg can predictably treat peripheral arterial disease (PAD) safely and effectively anywhere in the leg.

Link:
http://www.csi360.com/diamondback360.html

St Jude's New C7-XR OCT Intravascular Imaging System

St. Jude Medical to Showcase New Lesion Assessment Technology at TCT 2010

St. Jude Medical, a global medical device company, will highlight recently launched technology, including its new Optical Coherence Tomography (OCT) product platform, at the 22^nd annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C. The new C7-XR(TM) OCT Intravascular Imaging System complements the company's PressureWire(TM) Fractional Flow Reserve (FFR) measurement technology platform, offering physicians a new diagnostic standard for comprehensive intravascular lesion assessment.

The C7-XR OCT Intravascular Imaging System is a leading imaging technology platform that aids physicians in the diagnosis and treatment of cardiovascular disease. The C7-XR System uses near-infrared light to create high-resolution images that allow physicians to visualize and measure important vessel characteristics otherwise invisible or difficult to assess with older imaging technology. The St. Jude Medical OCT product platform expands the company's lesion assessment portfolio, which includes the recently launched PressureWire(TM) Aeris FFR Measurement System, and adds anatomical knowledge to the physiological information provided by FFR measurements. While FFR accurately identifies which lesions to stent, OCT-guided treatment can be especially important for the assessment of stent placement because it shows precisely how the stent is positioned against the artery wall.

St. Jude Medical is the first to offer both OCT and FFR technologies .

In addition to guiding stent selection, the C7-XR System provides physicians with post-stenting information by evaluating the position and deployment of the stent. At follow-up, the OCT technology provides detailed information regarding the inner lining of the vessel and whether there is a reoccurrence of the blood vessel narrowing.