Companies

Biotronik now boasts one of the longest drug-eluting stents on the market across all diameters with the market release of new 35 and 40 mm versions of Orsiro, the industry’s first hybrid Drug Eluting Stent (DES) featuring a bioabsorbable polymer.

Biotronik, has used the annual European Society of Cardiology event at which to announce what it calls ground-breaking results from its IN-TIME study. This is the first randomized, controlled trial worldwide, and demonstrates a significant reduction in all-cause mortality in heart failure patients with implant-based remote monitoring.

Back in May, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory of five product … continue reading “FDA Class I Recall for Stryker Spine’s OASYS Midline Occiput Plate”

St. Jude Medical, Inc., has gained CE Mark approval of its next-generation EnligHTN™ Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension. The company promises a time reduction from 24 minutes using its first device, to just 4 minutes.

Cardiovascular technology company Volcano Corporation has signed an agreement to acquire the Pioneer Plus™ diagnostic ultrasound transducer and percutaneous catheter from Medtronic, Inc. in a transaction that is expected to close by the end of August.

Zimmer’s PSI Shoulder utilizes 3D visualization software to allow a surgeon to create a customized surgical plan for each patient, and then provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the plan.

Needle-free, wireless continuous glucose monitoring device company Echo Therapeutics has parted company with its CEO, Dr Patrick Mooney, for reasons not thus far disclosed. Board member Robert Doman is stepping into the breach for the time being.

Edwards Lifesciences Corporation announced that the injunction against sales of Medtronic’s transcatheter heart valves in Germany had gone into effect. In a magnanimous gesture, Edwards is allowing for exceptions where its own Sapien valve is not indicated, but Medtronic’s CoreValve is.

Abbott has expanded its global peripheral technology portfolio with the acquisition of IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional radiologists, vascular surgeons and interventional cardiologists.

Boston Scientific Corporation continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath. The company says these products join its growing portfolio of next generation EP tools designed to redefine ablation technology.

Medtronic has posted financial results for its first quarter of fiscal year 2014, ended July 26, 2013. It’s forecasts for revenue and EPS for FY 2014 remain as stated in last year-end financials, although sales estimates were a smidge lower than anticipated by analysts.

So, five years after first getting a CE mark nod, Medtronic now has enough data to support its peripheral angioplasty balloon as far as module 1 of a PMA submission. Did EU regulatory authorities jump the gun too early or was the US hurdle too high for Invatec ’til Medtronic came along?

Boston Scientific has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of its Innova™ Self-expanding Stent System.

C. R. Bard, Inc. is to acquire privately-held Medafor, Inc., a leading developer and supplier of plant based hemostatic agents. The purchase price of $200 million will be paid at closing, expected to occur later this year, and future contingent payments up to an additional $80 million are based on specific revenue-based milestones through June 30, 2015.

St. Jude Medical adds ablation catheter with contact-force measurement to its industry-leading atrial fibrillation portfolio and accelerates U.S. timeline for AF ablation indication.

Last month we trailed the forthcoming acquisition by Abbott of privately held ophthalmic device company OptiMedica Corporation. And now the ink’s drying on the deal which sees Abbott’s vision care business expand into the femtosecond laser-assisted cataract surgery market.