New LV Assist Device Shows Benefits in High-Risk PCI Patients

Introduced to the U.S. market in 2008 as an upgraded alternative to the intra-arterial balloon pump, the Impella 2.5 showed clear signs of better performance in high-risk patients undergoing percutaneous coronary intervention in a multicenter, randomized trial with 447 patients.

PROTECT II was a prospective, multicenter, randomized, controlled trial of the Impella Recover LP 2.5 system vs. IABP (intra-aortic balloon pump) in patients undergoing nonemergent, high-risk PCI. The trial began in November 2007 at 67 U.S. sites, 4 sites in Canada, and 1 site in the Netherlands. It enrolled patients with either unprotected left main coronary disease and a left ventricular ejection fraction of 35% or less, or patients with triple-vessel coronary disease and an ejection fraction of 30% or less. The primary end point was the 30-day rate of death, MI, stroke, need for repeat revascularization, need for cardiovascular surgery or vascular surgery for limb ischemia, acute renal dysfunction, increased aortic insufficiency, severe hypotension, need for cardiopulmonary resuscitation, ventricular tachycardia, or failure to reopen the target coronaries by PCI. 


<http://www.internalmedicinenews.com/news/cardiovascular-disease/single-article/new-lv-assist-device-shows-benefits-in-high-risk-pci-patients/78c83fc5c2.html>

SCAI Releases First Report on Transradial Access for Angioplasty and Stenting

As interventional cardiologists increasingly perform angiography or angioplasty and stent procedures via radial (wrist) access versus femoral (groin or upper leg) access, it will be imperative to develop training and competency guidelines, according to the first report from the Society for Cardiovascular Angiography and Intervention's (SCAI) Transradial Working Group released today at the SCAI 2011 Scientific Sessions and published in Catheterization and Cardiovascular Interventions. The report reviews issues such as patient selection and preparation, artery access, catheter and therapy selection, primary PCI, potential complications and training for intervention cardiologists performing procedures via radial access.

Radial access is quite common around the world, though it still remains relatively unused in the United States. Recent research, including the RIVAL Trial presented at the 2011 American College of Cardiology (ACC) 60th Annual Scientific Sessions, has shown radial access is a safe and effective technique, can increase survival for heart attack patients, and is often preferred by patients over femoral access. However, published guidelines for the procedure and training are not yet available.

http://pr-usa.net/index.php?option=com_content&task=view&id=718941&Itemid=30

Atrium and Kaneka Launch Xpress-Way™ RX Extraction Catheter in the U.S.

Atrium Medical Corporation and Kaneka Corporation are proud to announce the introduction of the Xpress-Way™ RX Extraction Catheter. Xpress-Way RX has recently received FDA 510K clearance and is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corporation (Osaka, Japan) and Atrium Medical Corporation (Hudson, NH) is the exclusive distributor of the Xpress-Way RX in the U.S.

Thrombus aspiration uses the suction force generated from a syringe to pull soft fresh thrombus from a vessel. Thrombus can form throughout the body, but manual thrombus aspiration is commonly used in patients that have heart attacks. The main cause of heart attacks is due to a plaque rupture in one of the major coronary arteries, which causes a blood clot to form reducing blood flow and depriving the heart muscle downstream of oxygen rich blood. Manual thrombus aspiration is one tool used by interventional cardiologists to remove the blood clot and restore critical blood flow to the heart muscle.

About Xpress-Way™ RX

The Xpress-Way™ RX Extraction Catheter is an ultra low profile manual aspiration system designed for the removal of fresh, soft emboli, and thrombi in both coronary and peripheral vessels. Xpress-Way RX incorporates an innovative removable stylet and has been designed with enhanced pushability, anti-kinking, trackability, and crossability which allows for unmatched deliverability and market leading performance. Outside the United States, the Xpress-Way RX is marketed as the Thrombuster II (Kaneka Corporation, Osaka, Japan).

Abbott Announces Launch of Catheter-Based MitraClip® System in Australia for Mitral Regurgitation, the Most Common Heart Valve Condition

http://www.prnewswire.com/news-releases/abbott-announces-launch-of-catheter-based-mitraclip-system-in-australia-for-mitral-regurgitation-the-most-common-heart-valve-condition-118905689.html

Abbott (NYSE: ABT) today announced the launch of the company's catheter-based MitraClip® system for the treatment of mitral regurgitation (MR) in Australia. The MitraClip device, which has received Therapeutic Goods Administration (TGA) approval, offers a new treatment option for patients suffering from MR, a debilitating heart valve condition.  
Chronic, severe MR is often associated with heart failure and can result in death if left untreated. The MitraClip system represents an important therapeutic option for patients with this debilitating disease, many of whom may have no other treatment options. 

Major New Study Shows Aortic Valve Replacement Via Catheter Produces Better Outcomes Than Traditional Open-Heart Surgery

http://www.prnewswire.com/news-releases/major-new-study-shows-aortic-valve-replacement-via-catheter-produces-better-outcomes-than-traditional-open-heart-surgery-119153104.html

A major new study presented today at the yearly scientific meeting of the American College of Cardiology (ACC) in New Orleans shows conclusively that replacing defective aortic valves in elderly patients through non-invasive "catheterization" – rather than through much more invasive open-heart surgery – leads to significantly better outcomes.

The new clinical trial study (PARTNER cohort A: Transcatheter valves noninferior to surgery), documents important scientific evidence for the fact that a new "transcatheter" approach to aortic heart valve replacement is safer and less strenuous for older patients than the older open-heart procedure.

 

Catheter-Based Aortic Valve Replacement Equal to Surgery

http://www.ptca.org/news/2011/0403_PARTNER.html


Catheter-Based Aortic Valve Replacement Equal to Surgery


The much-anticipated findings from the PARTNER trial, comparing the standard surgical procedure of aortic valve replacement (AVR) to the newer and, as of yet, unapproved in the U.S. transcatheter-based version (TAVR), were presented today at the American College of Cardiology's 60th Annual Scientific Session in New Orleans -- and the two methods of treatment were judged virtually equivalent at one year.


The study reported results from "Cohort A" of the PARTNER trial which randomized patients who were at high risk for surgery either to the tried-and-true surgical approach or to treatment with the SAPIEN valve, manufactured by Edwards Lifesciences (NYSE: EW ), which is delivered via catheter, usually via the femoral artery.

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Boston Scientific Announces First Implantations of OMEGA(TM) Platinum Chromium Coronary Stent System

Boston Scientific Announces First Implantations of OMEGA(TM) Platinum Chromium Coronary Stent System

Third-Generation Bare-Metal Stent Implanted in the UK


Boston Scientific Corporation (NYSE: BSX) today announced the first implant in the UK of the OMEGA(TM) Platinum Chromium Bare-Metal Coronary Stent System which recently received CE Mark approval. The first implant was performed by Dr Neal Uren, Consultant Cardiologist, Royal Infirmary of Edinburgh.


The OMEGA Stent System incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and is intended to provide interventional cardiologists a bare-metal stent with improved acute performance in treating patients with coronary artery disease.

The OMEGA Stent System is part of the Company's PtCr Stent series, which includes the TAXUS(R) Element(TM) Paclitaxel-Eluting Stent and PROMUS Element(TM) Everolimus-Eluting Stent Systems. All three stents feature the novel PtCr alloy and an innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The higher density alloy provides superior visibility while permitting thinner struts compared to prior-generation stents[1]. The enhanced delivery system features a dual-layer balloon and is engineered to improve access to challenging lesions.


The OMEGA Stent is offered in 48 different sizes ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm.