Medical Device News Resource, for the Global Medical Device Industry

CoreValve® First TAVI To Get Valve-In-Valve CE Mark

Medtronic, Inc. has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut™ transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves.

Medlatest’s weekly editorial online now

EuroPCR has been the main focus of medlatest's editorial this week. We've spotted a growing trend for companies to use vehicles like ours to get their news across. Never has that been more evident than this week, which has seen an unprecedented number of winning tales.

Symplicity™ HTN-3 Renal Denervation Study Enrollment Complete

Medtronic, Inc. has announced it has finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension. The company is hoping this is a landmark in its progress towards U.S. approval.

OrthoSensor™ Intelligent Knee Instruments Obviously Adding Value As Stryker Extends Agreement

OrthoSensor's VERASENSE™ Intelligent Instrument System is obviously complementing Stryker's Triathlon® Knee System as the two companies agree to extend their co-marketing arrangement.

PillCam Starting To Look Like A Diagnostic Option Say Studies

It’s Digestive Disease Week(DDW) in Orlando’s Orange County Convention Center. At the event, PillCam capsule endoscopy pioneer Given Imaging Ltd, has announced data from several European studies. Data confirms the effectiveness of PillCam COLON in detecting colonic lesions in patients following incomplete colonoscopies and monitoring diverse digestive diseases in both adults and children. Background We’ve covered [...]

99% Freedom From All-Cause Mortality At 30 Days Says Direct Flow Medical TAVI Trial

This week's EuroPCR event saw the publication of a study in which patients were treated with the Direct Flow Medical® Transcatheter Aortic Valve System. The DISCOVER Trial full 30-day outcomes suggested minimal post-procedural aortic regurgitation and adverse events.

St.Jude Medical Kicks Off EnligHTNment Study At EuroPCR

St. Jude Medical, Inc. has taken the opportunity presented by EuroPCR in Paris this week, to announce the start of its landmark EnligHTNment clinical study. This is the largest randomized, prospective trial to determine whether renal denervation and medication offers additional health benefits beyond lowering blood pressure in patients with uncontrolled hypertension. Background Renal denervation [...]

FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters

The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. It seems the device, which is available over-the-counter, can generate incorrect test results at extremely high blood glucose levels. Background The FreeStyle InsuLinx Blood Glucose Meter is an Over-the Counter single patient-use device intended to [...]

Study Suggests Genous “Pro-Healing” Stent Lowers Stenosis Rate vs Bare Metal

Results of Randomized JACK-EPC Trial Published in Minerva Cardioangiologica suggest that the antibody coating on OrbusNeich's Genous stent may be doing its job and attracting endothelial progenitor cells, thereby accelerating stent "healing".

Six Month Lower Mortality Rate In STEMI Patients For MGuard Embolic Protection Stent vs BMS Control

InspireMD 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrate that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.

Five Year Data For Axxess™ Self-Expanding Bifurcation DES

New long-term data from the DIVERGE study, presented at this week’s EuroPCR 2013 congress has shown that the use of the Axxess™ drug-eluting stent (DES) for the treatment of complex coronary bifurcation lesions resulted in low levels of both MACE and VLST over a five-year period. Manufacturer Biosensors International tells us Axxess is now the [...]

Study Says Optical Biopsies May Help Confirm And Rule Out Pancreatic Cystic Tumors

Optical Biopsies captured with Mauna Kea Technologies' new AQ-Flex™ 19 Miniprobe were deemed easy to interpret with short learning curve for both novice and expert endoscopists according to data presented at Digestive Disease Week 2013

Could New BioMatrix™ DES 5000 Patient Registry Data Result In Shorter DAPT Course?

Stent maker Biosensors, tells us that new registry data presented this week at EuroPCR 2013 has confirmed that the BioMatrix™ drug-eluting stent (DES) family is safe over a 12-month period in a “real-world” population of 5559 patients. This has led the studies principal investigator to suggest use of DES like BioMatrix could avoid the use [...]

Pentax Medical Claims Industry’s Highest Res HD+ Imaging Technology For Flexible Endoscopy

PENTAX Medical Company, a healthcare industry leader in endoscopic imaging has announced the U.S. launch of the EPK-i®5010 Video Processor with Pentax i-SCAN™, the industry’s highest resolution HD+ imaging technology for flexible endoscopy. Background Studies have shown EPK-i®5010 with Pentax i-SCAN™ may improve detection and characterization of disease by digitally enhancing blood vessels and mucosal [...]

CE Mark For World’s Longest Coronary Drug Eluting Stent

The newly CE marked XIENCE Xpedition™ 48 coronary stent leverages the well established design and clinical outcomes of the XIENCE Family of Drug Eluting Stents. A longer stent, compared with multiple short stents has the potential to reduce overall procedural costs, particularly in very long lesions most often seen in patients with diabetes.

FDA Clears Covidien’s Nellcor™ Pulse Oximetry Motion Claims

Covidien's Nellcor™ pulse oximetry systems have received U.S. FDA 510(k) clearance for so-called "motion" claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio.