Medtech company Mercator says achieveing CE Mark approval for its Cricket™ and Bullfrog® Micro-Infusion Catheters clears pathway for launch of adventitial drug delivery technique into European Peripheral Artery Disease Market.
Regulatory
FDA Clears ArthroCare® SpeedLock® HIP Knotless Fixation Implant
ArthroCare® Corp. has received clearance from the U.S. FDA for its SpeedLock® HIP Knotless Fixation implant. SpeedLock HIP is a PEEK implant that is indicated for soft tissue fixation to bone in the hip.
CE Mark For Medtronic’s Engager Transcatheter Valve, Based On Positive Clinical Study Outcomes
Transcatheter heart valves hit our news pages seemingly every week. Today its the turn of Medtronic with the news that its Engager valve, optimised for transapical delivery, has gained CE mark approval, based on solid looking numbers from its pivotal multi-center study.
CE Mark For Claret Medical’s Montage 2™ Embolic Protection Filter
Claret Medical has gained CE mark approval for its Montage 2™ which becomes the only approved filter system protecting the carotid arteries capturing embolic debris during intravascular procedures such as Transcatheter Aortic Valve Repair.
FDA Clearance For Surgery Rehearsal Platform™
Surgical Theater, LLC™, has received FDA clearance for its Selman Surgery Rehearsal Platform™(SRP), making it the only patented and FDA cleared platform for cerebral and spine pre-surgery rehearsal in the marketplace. And its clever stuff, using standard scanned images from the patient, the SRP generates 3D patient specific and accurate models showing the interaction between life-like tissue and surgical instruments.
Medtronic Gains First FDA Approval Under New Early Feasibility Study Rules
Medtronic’s new Transcatheter pulmonary valve study, approved by the FDA, represents the first time this new draft guidance has been employed. The result should be a better product, earlier to market, if the klegislation is doing its job.
FDA Class I Recall For Lumenis VersaCut Tissue Morcellator
Israeli device company Lumenis Limited is recalling certain models of VersaCut Morcellator devices because of the potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing.
FDA Clears New Sizes Of Resolute Integrity Coronary Stent For Long Lesions Common Among Diabetes Patients
Medtronic, Inc. has announced that the U.S. FDA has approved the 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm. The longer lengths include an indication for patients with diabetes in whom longer lesions are common.
CE Mark For NxStage Single Needle for Dialysis Patients
Last week we wrote about NxStage® and its new CE approval for its System One dialysis machine. Now the company has announced that its single needle technology, OneSite™, has received CE Mark approval.
FDA Approves First Single-Lead ICD with Atrial Sensing
Biotronik has announced the FDA approval of its Lumax 740 DX System. This novel device is a first-in-class implantable cardiac defibrillator (ICD) that utilizes a single lead with atrial sensing capabilities.
Alcon On FDA’s “Very” Naughty Step For Improperly Marketing Its Laser
This envelope must have been an unpleasant one to open. Following an inspection of Alcon Inc.’s Aliso Viejo site in California, the agency wrote a stinging warning letter to the company citing a number of serious shortfalls in its activities.
FDA Class I Recall As DePuy’s LPS Diaphyseal Sleeve May Not Accommodate Physiologic Loads
The FDA has issued a Class I recall of DePuy’s LPS Diaphyseal Sleeve the company having found that the Sleeve to its Base taper connection may not be sufficient to accommodate potential physiologic loads under some circumstances.
NxStage Announces CE Mark Approval for New High Flow Capabilities with System One
Dialysis product company NxStage® Medical, Inc. has announced CE Mark approval for new high flow capabilities with the NxStage System One™. With this approval, the Company expects to bring this advancement to customers in countries that recognize the CE Mark approval process later this year.
Europe’s Most Popular Breast Implant Gets FDA Nod
Allergan’s Natrelle® breast implant line now extends to a newly FDA approved shaped silicone gel option. The implant is already available in Europe and has proven popular, not least because of its anatomical shape.
FDA Clears Dallen Medical’s New Compressyn™ Staple For Rigid Small-Bone Fixation
Dallen Medical has received FDA 510(k) clearance for the Compressyn™ Staple for small bone fixation, specifically in foot, ankle, and hand applications. The company says its patented technology offers significant improvement over existing products when it comes to fixation and dynamic compression.
Small, MRI Compatible And With Remote Monitoring: What’s Not To Like About Biotronik’s Newly CE Marked Ilesto 7 ICD/CRT-D Devices?
Biotronik has announced that its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE approval. The device family includes the one of the world’s smallest ICDs and is MRI compatible as well as being equipped with Biotronik Home Monitoring® technology.