Products

Medtech Market Intelligence company Millennium Research Group (MRG), has launched a new report which looks into the future for laparoscopic surgery devices in the United States. MRG believes the market will see moderate growth, culminating with a market value of $4.5 Billion by 2022.

Biotronik has seen its clever, electrospun coated stent gain CE mark approval for use in cases of acute coronary vessel perforation. The clever part lies in the electrospinning, which creates a single, integrated coating without the need to sandwich the stent.

Medtronic is no doubt hoping that by casting the net a little wider it may ultimately gain an indication for its Symplicity Renal Denervation System to be used on patients with less severe uncontrolled Hypertension.

It’s ironic that an embolus filter should find itself the subject of a recall for presenting a risk of embolus. It’s also reassuring that the company, Edwards Lifesciences, should take such a prudent step without having identified a single occurrence of the risk for which its device is being recalled.

Diabetes solutions giant Novo Nordisk, has gained FDA approval for its pre-filled insulin pens which it says avoid the patient challenges presented by other pre-filled pens.

Its been a good week for Reverse Medical Corporation, which has seen CE Mark approval, FDA 510k clearance and initial clinical use of its ReVerse® Microcatheter product line for intracranial neurovascular use.

Musculoskeletal device specialist DJO Global, Inc., tells us its Match Point System™ patient-specific shoulder instrumentation has seen its first use in Reverse® Shoulder System cases in Australia Florida.

FDA’s Mitraclip approval now means it’s available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. New data at TCT2013 provides compelling clinical support for the device in this patient group.

Neuromonitoring device company Raumedic has gained FDA 510(k) clearance to market Neurovent®-PTO. The company says this is the only marketed device that combines measurement of intracranial pressure , intracranial temperature and oxygen partial pressure in one Catheter.

MIS spine developer NLT Spine, has seen two of its generation 2.0 products designed for spinal fusion procedures received FDA 510(k) clearance. PROW FUSION™ and eSPIN™ both target the lumbar interbody fusion market, which currently represents an opportunity of approximately $1.3 billion globally.

MIS device company, AngioDynamics has gained CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours. Under the CE Mark approval the AngioVac cannula is also approved for removal of fresh, soft thrombi or emboli.

Boston Scientific’s Lotus™ Transcatheter Aortic Valve Implant has gained CE Mark approval as a treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement.

Times are tough and healthcare providers are permanently squeezed. Does that mean a device company offering quality devices, but no rep support will be able to tap into the market on a cost basis?

Back in March things were looking a little up in the air for MitraClip as the FDA’s circulatory devices panel gave the clever device its thumbs up, despite the FDA’s summary document at the time saying there were still concerns. Seven months on and the device has received its US approval and will launch immediately in the United States.

Cardiovascular Systems, Inc. has received FDA PMA approval for its Diamondback 360® Coronary Orbital Atherectomy System, the first such device to gain approval as a treatment for severely calcified coronary arteries for over twenty years.

The EU parliament’s plenary vote has gone through, with many of the ENVI committee’s proposals left intact. The good bits at least. The plainly bonkers concept of a European “PMA-style” approval process for higher risk devices has seemingly gone.