Renal Denervation is probably the biggest buzzphrase in new therapies right now, given the size of the problem it purports to address. Medtronic has seen more promising data published at ESC, suggesting patients treated with its Symplicity™ system benefit from sustained and meaningful BP reduction at 18 months
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FDA And CE Approval For Medtronic’s New Cryoballoon Means Improved Pulmonary Vein Isolation
Medtronic’s Arctic Front Advance™ Cryoablation System now delivers cold therapy to a larger area more evenly, the company claiming that this will aid cardiologists in delivering cardiac ablation therapy.
Tornier’s OrthoHelix Acquisition Will Bring Foot & Ankle Plates To Europe
Tornier buying OrthoHelix will bring innovative Foot & Ankle technologies to Europe as well as high growth, line extension and gross margin to Tornier.
Cook Medical’s Ongoing Zilver® PTX Trial Data Show Higher Freedom From Target Lesion Revascularisation At 3 Years Than Angioplasty and Bare Metal Stents
Cook Medical’s Zilver® PTX paclitaxel-eluting peripheral vascular stent demonstrated 83.0 percent freedom from Target Lesion Revascularisation at 36 months in the PTX group, compared to 70.2 percent for patients treated with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study.
Flammable Bone Putty: Are We Missing Something (Or Rather Has Someone Else)?
So who dropped the ball? It looks like one of Synthes Hemostatic Bone Putty’s constituents is flammable, which makes it look like the culprit in the flammable bone putty debacle.
Burns Concern Provokes Covidien’s Recall Of Certain High-Power Single Use Grounding Pads
Covidien is conducting a voluntary recall of certain production lots of the DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that contain DGPHP RFA High-Power Single Use Grounding Pads.
Medtronic’s First Quarter Highlights Emerging Markets
Before we saw the numbers we were backing the line that it would be stents up, pacing and spine down, and so it came to pass. Medtronic’s numbers show the importance of emerging markets and contributions from its newly acquired businesses as the company posts 5% revenue gains.
Medtronic’s Newly CE Marked Cardiac Resynchronisation Therapy Devices Preserve Normal Heart Rhythm
Medtronic has announced CE mark approval for two new CRT devices which automatically adapt to patients’ electrical rhythms, improving response to life-saving therapy.
CE Mark And EU Launch For Abbott’s XIENCE Xpedition™ “Extraordinarily Deliverable” Drug Stent
Abbott has announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has gained CE Mark approval for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries.
St. Jude Sells Venture Guidewire-Directing Catheter To Vascular Solutions
Presumably with its strong focus on peripheral vascular surgery, Vascular Solutions sees more potential than St.Jude does for this steerable guidewire catheter… enough to pay $3M for residual inventory and rights.
Device Alert: Baxter Sterile Water For Irrigation
One specific LOT of Baxter’s sterile water for irrigation may be contaminated by a bacterium. As a precautionary measure the company is acting and UK’s regulatory body has issued a device alert calling for quarantining of identified product as further investigation is performed.
CE Mark for Gore’s Hybrid Vascular Graft Signals Preservation Of Dialysis Access Sites
W L Gore’s Hybrod Vascular Graft was FDA cleared two years ago, and now the company has announced it has its CE Mark, which it expects will bring a new level of utility to Vascular Surgeons in Europe.
How Must It Feel To Have A Recalled Product Inside You?
FDA has issued updated guidance on the clinical management of problematic Riata and Riata ST ICD leads. We take a considered look at how patients must be feeling and how well they’re getting looked after through this whole stressful experience.
Covidien’s Shiley Recall Now Becomes FDA Class 1
As is often the case a company’s voluntary recall has morphed into the FDA Class 1 variety. This time it’s Covidien’s Shiley Adult Tracheostomy Tubes which have reportedly suffered disconnection and leakage.
Avoiding Unnecessary Shocks: First U.S. Patient For ICD Equipped With SMART® Detection
A unique algorithm in Biotronik’s Lumax 740 ICD differentiates atrial from ventricular arrhythmias to avoid risk for potential long-term medical consequences of painful and inappropriate shocks.
In The M&A Mood: Getinge, Conmed And Ingen
It looks like only the due diligence and PR teams are not on holiday this week as we see a flurry of announcements about M&A activity in medical devices, from 3D HD cameras to Therapeutic Supports to “Nutraceuticals”.