Cardiology Product Guide

Cialis’ active ingredient approved for a new use

Jim Marino — Tue, 07 Jul 2009 04:54:32 +0000

The FDA has approved tadalafil, the active ingredient in the erectile dysfunction drug Cialis, to improve exercise ability in people with pulmonary arterial hypertension, which is a rare, life-threatening lung disorder. This disorder causes high blood pressure in lungs. Tadalafil, manufactured by the drug company Lilly, will be available in the U.S. as Adcirca in August by United Therapeutics Corporation.

FDA approves Multaq for heart rhythm disorders

Jim Marino — Tue, 07 Jul 2009 04:54:19 +0000

French drug company Sanofi-Aventis announced that the US Food and Drug Administration (FDA) had approved its heart drug and potential blockbuster product Multaq. Multaq promotes a normal heart rhythm in people with atrial fibrillation or atrial flutter. These conditions cause the heart to beat too quickly and can prevent it from pumping blood correctly.

CircuLite(R) Receives ISO 13485 Certificate Of Registration For The Synergy™ Pocket Micro-Pump

Jim Marino — Fri, 02 Jan 2009 08:41:11 +0000

CircuLite, Inc. has announced that it has received ISO 13485 certificate of registration from BSI Group for the Company’s Quality Management System in Saddle Brook and Aachen for the design, manufacture and distribution of the Synergy™ Pocket Micro-pump for the treatment of chronic heart failure. ISO 13485 is a regulatory certification for the international medical industry, created by the International Organization for Standardization (ISO), which defines standards for the design, development, production and distribution of medical devices, and also ensures conformity with certain quality controls in the development of safe and effective devices.

Medtronic Debuts Medical Device in U.S. Designed to Improve Treatment of Aortic Aneurysms

Jim Marino — Wed, 17 Dec 2008 11:46:06 +0000

Medtronic has announced the U.S. launch of the Talent Abdominal Stent Graft on the Xcelerant Hydro Delivery System. EVAR is a treatment for aortic aneurysm, a bulge or weakening in the body’s main artery that can rupture with fatal consequences if left untreated. EVAR involves the navigation of a stent graft, via the body’s arteries, to the aorta. The stent graft is then deployed to create a tube within the aorta, reducing pressure on the aneurysm and the risk of rupture. EVAR is a minimally-invasive alternative to open surgical repair.

Medtronic Launches Sprinter(R) Angioplasty Balloon Cathethers On Rapid Exchange

Jim Marino — Mon, 08 Dec 2008 10:30:27 +0000

Medtronic, Inc. has announced the U.S. market launch of the Sprinter Legend (semicompliant) and the NC Sprinter (noncompliant) balloon dilatation catheters on a rapid exchange delivery system. Recently approved by the U.S. Food and Drug Administration, the Sprinter Legend balloon catheter provides the latest innovations in balloon technology and is equipped to address difficult lesions in coronary angioplasty procedures. The Sprinter Legend balloon catheter features the lowest pre-dilatation profiles, making it suitable for use in challenging lesions, as well as allowing for the use of two balloons simultaneously in a small, guide catheter.

TomTec And Medis Launch Joint Cardiac Imaging And Analysis Product

Jim Marino — Fri, 28 Nov 2008 09:16:41 +0000

TomTec and Medis have announced the launch of a joint cardiac imaging and analysis product for X-ray angiography and ultrasound. The combined solution is a fully integrated software package that consists of TomTec’s Image-Arena™ and Medis’ QAngio® XA quantification software. It will be available as one platform that can be integrated into the products of partnering medical device manufacturers and that connects to existing PACS, HIS, CPACS and CVIS in hospitals. The software solution drastically reduces the integration effort for industry partners and for hospitals that want to optimize their imaging and analysis processes and data management.

Medtronic unveils Endeavor Sprint drug eluting stent on a rapid exchange

Jim Marino — Mon, 17 Nov 2008 13:19:59 +0000

Medtronic, Inc. has launched the Endeavor Sprint drug eluting stent (DES) on a rapid exchange (RX) delivery system in the U.S. The Endeavor Sprint system uses Sprinter ™ balloon catheter technology. The system puts the highly deliverable Endeavor DES on an enhanced delivery platform. This makes Medtronic’s flagship DES even easier for physicians to deliver to the site of coronary blockages. The Endeavor Sprint drug eluting stent system is the latest innovation to come out of our robust product pipeline in CardioVascular.

FDA nod to Bard’s Flair™ Endovascular Stent Graft

Jim Marino — Thu, 06 Nov 2008 06:26:19 +0000

The U. S. Food and Drug Administration has granted approval to C. R. Bard, Inc. for marketing its Flair™ Endovascular Stent Graft with an optimized delivery system. The device consists of a self-expanding Nitinol stent encapsulated within the proprietary ePTFE graft material of Bard. The product has received the indication for use in the treatment of stenoses in synthetic arteriovenous bypass grafts. A six-month long study conducted by Bard showed that the placement of the device resulted in more than twice the primary patency of balloon angioplasty. “The Flair Endovascular Stent Graft represents the first interventional technology demonstrating superiority to balloon angioplasty in maintenance of access patency.

CE Mark approval for Cook Medical’s microcatheter

Jim Marino — Wed, 29 Oct 2008 14:04:46 +0000

Cook Medical has received the CE Mark approval for its MiraFlex™ High Flow Microcatheter. Designed to complement the company’s existing embolisation products and coils, the device represents the newest improvement in micro-catheter technology. It enhances traceability necessary to access the most distal vasculature. Having an inner diameter of .025 inch, the catheter is approved for use in small vessels. It enables coil delivery in the finest way.

FDA nod to Endologix’s IntuiTrak™ Delivery System

Jim Marino — Mon, 27 Oct 2008 04:36:24 +0000

The U.S. Food and Drug Administration has approved Endologix, Inc.’s IntuiTrak™ Delivery System. The novel system will facilitate minimally invasive delivery. It will help deploy the Powerlink stent graft [indicated for endovascular repair of AAA abdominal aortic aneurysms (AAA)]. The device has improved flexibility. It features advanced hemostasis control. An integrated sheath introduces ancillary devices during AAA procedure, reducing blood loss and the procedure time.