Medical Product Guide

Boston Scientific gets approval from FDA for Apex™ PTCA Dilatation Catheter

Jim Marino — Fri, 14 Nov 2008 15:11:56 +0000

Boston Scientific Corporation has announced that it has received approval from the U.S. Food and Drug Administration to market its Apex™ PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter. It has been developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. The Apex Catheter is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms. It represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment™ inner shaft for improved pushability and flexibility.

FDA approval for Salix Pharmaceuticals’ APRISO

Jim Marino — Thu, 06 Nov 2008 07:45:52 +0000

The U.S. Food and Drug Administration has granted the marketing approval to Salix Pharmaceuticals’ APRISO (mesalamine) extended-release capsules 0.375 g. A locally-acting aminosalicylate, APRISO has been approved for the remission of ulcerative colitis (UC) in adults. APRISO is the only mesalamine product to receive an FDA approval as once-daily drug for the maintenance of remission of UC. Also, it is the first ever 5-ASA with Intellicor(TM) extended release delivery technology. The product will be available to physicians by early 2009.

FDA expands indication for Hospira’s Precedex

Jim Marino — Fri, 31 Oct 2008 05:37:46 +0000

The U.S. Food and Drug Administration has expanded the indication for Hospira, Inc.’s Precedex(R) for use in non-intubated patients needing sedation before or during surgical procedures. Anesthesiologists, now, can administer Precedex safely for a growing number of out-patient applications like ophthalmic and orthopedic procedures.The broader indication is based on the results of two clinical trials involving 431 patients.

Spiration, Inc’s IBV® Valve System receives HDE approval from FDA

Jim Marino — Wed, 29 Oct 2008 05:04:09 +0000

The U.S. Food and Drug Administration has given Humanitarian Device Exemption (HDE) approval to Spiration, Inc. to use its IBV® Valve System for controlling air leaks which may become prolonged after procedures such as lung volume reduction surgery. This is the first approval from FDA for a bronchial valve implant for the lungs. Conventional treatments such as surgery can lead to complications and are expensive. This minimally invasive system is a safer and cheaper alternative.

Neuronetics’ Neurostar receives FDA approval

Jim Marino — Mon, 27 Oct 2008 05:00:13 +0000

The Food and Drug Administration (FDA) has given the approval to Neuronetics Inc.’s Neurostar [a transcranial magnetic stimulation (TMS) device] for use in the treatment of depression. The non-invasive tool stimulates the brain by transmitting magnetic pulses to the skull. The device will help the adult patients who have not benefited from anti-depressants. Also, this therapy has no risks as associated with electric shock therapy and surgically implanted electrodes.

FDA nod to InnerCool’s Rapid Blue System

Jim Marino — Mon, 27 Oct 2008 03:55:58 +0000

The U.S. Food and Drug Administration has given 510(k) clearance to Cardium Therapeutics’ operating unit InnerCool Therapies, Inc. for the commercialization of its RapidBlue(TM) System, a system to regulate body temperature. The closed loop catheter-based system of the device modulates body temperature by circulating saline within the catheter’s interior. Underwriters Laboratories found that the system met all the medical electrical safety standards including UL 471 Standard for commercial refrigerators, the first global certification for an endovascular thermal regulating device.

Ce Mark na d FDA approval to St. Jude’s Angio-Seal™ Evolution™ Vascular Closure Device

Jim Marino — Fri, 17 Oct 2008 11:04:22 +0000

The U.S. Food and Drug Administration and the European medical regulatory authority have approved St. Jude Medical, Inc.’s Angio-Seal™ Evolution™ Vascular Closure Device. The device is designed to help physicians in sealing the femoral artery punctures that take shape during minimally invasive catheter-based procedures effectively. This enables faster achievement of hemostasis (stoppage of bleeding). Featuring a completely novel delivery system, it reduces the variability occurring during deployment of the system by physicians.

FDA approves HDE for Levitronix’s heart pump

Jim Marino — Tue, 14 Oct 2008 07:28:57 +0000

The U.S. Food and Drug Administration has given the approval in the form of a Humanitarian Device Exemption (HDE) for Levitronix’s CentriMag Right Ventricular Assist System providing patients in critical condition with temporary aid for the right ventricle of their heart. The heart pump supports the pumping action of a heart not functioning properly. The indication facilitates the development of the device for treatment of the severe right-side heart failure, which although uncommon, can lead to death. The device was found to be safe for use.

Covidien to launch Permacol™ Biologic Implant

Jim Marino — Mon, 13 Oct 2008 05:34:45 +0000

Covidien announced the launch of Permacol™ Biologic Implant, a biologic mesh for hernia repair. The implant joins Covidien’s line of products as a result of acquisition of Tissue Science Laboratories by the company. It will be available in the American and European markets in 2009. Containing improved porcine collagen, Permacol™ Biologic Implant brings together the clinical benefits of a biologic and a synthetic’s intra-operative efficiency. The hydrated and ready-to-use product can be cut or shaped as required, providing a suitable soft tissue repair.

Olympus to launch Spiration’s IBV® Valve System

Jim Marino — Fri, 10 Oct 2008 05:47:24 +0000

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.