Buoyed by healthy revenue growth from its Impella in-dwelling heart-assist device, Abiomed has reported a Q3 top line up 21% compared with the same period a year ago. Profits are also up with Q3 GAAP net income of $4.4 million compared to $2.7 million last year.
Companies
Medtronic’s Valiant Captivia Stent Graft Now FDA Approved for Aortic Dissections
Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.
Option to Acquire Haibo Technology Signals Abyrx’s Entry into Soft Tissue Hemostasis Market
Abyrx™, Inc., has announced it has entered the soft tissue hemostasis market with a commercial deal with Chinese company Haibo Biotechnology Institute’s (HBI) proprietary resorbable plant-derived soft tissue hemostat technology platform.
First UK Patient for Tiny Leadless Nanostim™ Pacemaker
St. Jude Medical, Inc. is trumpeting the first post-approval implant of the Nanostim™ leadless pacemaker in the U.K. The world’s first retrievable leadless pacemaker was implanted at St. Bartholomew’s Hospital in London, UK, by Professor Richard Schilling.
FDA OK’s Medtronic Pacemakers for Full-Body MRI Scans
Medtronic, Inc. has announced the U.S. FDA approval of its Medtronic SureScan® pacing systems that are compatible with use of MRI scanning on any region of the body.
IFU Changes Mean Codman Neuro’s TRUFILL® n-BCA Liquid Embolic System Gets Class I Recall Status
Codman Neuro has announced changes to the instructions for use for its TRUFILL® n-BCA Liquid Embolic System. It seems incorrectly mixed product can result in embolization or reflux, which has lead the U.S. FDA to label the company’s medical device correction notice as a Class I recall.
Intuitive Picks up Shape Sensing Technology for $30 Million
daVinci company Intuitive Surgical is to acquire a “shape-sensing” technology from its developer, Luna Innovations Inc. in a deal worth up to $30 million.
FDA Clearance for Covidien LigaSure™ Maryland Jaw
Covidien has received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition the company has completed all European requirements to CE Mark the product. It expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.
Europe-wide Release for Biotronik’s Passeo-18 Lux Peripheral Vascular Drug-Releasing Balloon
Cardiovascular device company Biotronik is in the news again with the announcement of its release of the Passeo-18 Lux Drug Releasing Balloon (DRB) in all countries accepting CE mark, following recent CE approval.
Has Covidien Realised the Emperor’s Naked?
Is Covidien’s sudden exit from the erstwhile next big thing that was Renal Denervation therapy a sign that they’re not up for the fight? Or is a combination of slow adoption and a clinical mountain to climb making this massive market opportunity shrink before their eyes to the extent that it’s no longer viable?
J&J Device Sales Grow
Johnson & Johnson has unveiled its Q4 figures which show an impressive 4.5% increase over the equivalent period a year ago. That’s not a bad return when we’re talking about $18.4 billion for one quarter. Figures include net impact of Synthes acquisition and DePuy Trauma divestiture.
Study Points to Savings with Remote Monitoring of ICD Patients
Biotronik is pointing to new study data showing that use of its Biotronik Home Monitoring® system has saved the French National Health Insurance system costs, in addition to being safe and efficient.
Shire Takes the Pain and Offloads DERMAGRAFT®
Global Pharma company Shire plc, is to sell what it calls its “Dermagraft assets” to Organogenesis Inc. for what could add up to $300 million, but for now looks like a $650 million loss.
It’s Win-Win: Confluent Suit Fits Integra Better than it did Covidien
Covidien has completed the sale of its Confluent Surgical product line to Integra LifeSciences Corporation for approximately $235 million in cash and is seemingly pleased to be rid of it. Integra will benefit from a highly complementary product.
Irish X-Bolt Orthopaedics Hopes Equity Round will see it through FDA
Hip fracture fixation company, X-Bolt Orthopaedics, based in Dublin, has completed an equity investment round of €1.8 million which it says will advance FDA clearance for its X-Bolt product in the US and fast track commercialisation of the product to the global export market.
J&J Offloads Ortho-Clinical Diagnostics Business for $4Bn+
In a deal worth $4.15 billion, private equity company The Carlyle Group is to acquire Johnson and Johnson’s Ortho-Clinical diagnostics business, signalling J&J’s departure from in-vitro diagnostic services business.