St. Jude Medical’s large European clinical trial of its Nanostim pacemaker is hoped to add to the building evidence supporting strong safety profile and performance of the world’s first leadless pacemaker.
Companies
FDA Approves First Trial of ICD in MRI
The U.S. FDA has said Biotronik can move onto phase C of its ProMRI study which will investigate the company’s MRI-compatible technology in its implantable cardioverter-defibrillator (ICD) devices.
K2M’s IPO will Build on Sales Growth to Fund Future Growth
Spinal technologies company K2M, Inc., put the wheels in motion for an IPO back in January. Now the company has filed the papers which could see it raise $100 million in order to fund debt repayments and future investment to build on an already healthily growing revenue stream.
Sorin Buys Oscor’s CRM Lead Business Including Manufacturing Facility
Italian Cardiovascular device company Sorin Group has announced the purchase of the Oscor Inc. lead business, including a lead manufacturing facility in the Dominican Republic for an aggregate value of approximately $20 million (Eur15.4 million).
CE Mark Approval and First Implants of Boston Scientific’s Ingevity™ MRI Pacing Leads
Boston Scientific Corporation has announced CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads.
Consumer Advocacy Group Advocates MRI for DePuy Pinnacle Patients
After all the hoo haa of the last few years pertaining to the damaging outcome of some metal-on-metal hip implants, US patient advocacy group The Drugs Watchdog has now issued a press release strongly suggesting DePuy Pinnacle all metal hip implantees contact it to discuss their options, the most likely suggestion being to demand an MRI.
CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent
Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation … continue reading “CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent”
AAOS 2014 Sees Launch of Smith & Nephew’s JOURNEY™ II Cruciate Retaining Natural-Motion Knee Replacement
Smith & Nephew has used the AAOS annual meeting at which to announce the launch of the JOURNEY™ II Cruciate Retaining knee replacement which it says will address about half of all knee replacement cases.
Smith & Nephew Planning Software Takes the Guesswork out of Hip Arthroscopy for Impingement
Smith & Nephew says its newly launched DYONICS PLAN system allows surgeons to visualize, assess and generate a comprehensive surgical report for each patient’s unique Femoroacetabular impingement surgery before that patient ever enters the operating room.
Stryker Completes Pivot Medical Acquisition
Stryker Corporation tells us it has completed its previously announced all-cash acquisition of Pivot Medical Inc., a move the Kalamazoo device company will hope enhances its position in the orthopaedic sports medicine and arthroscopy specialties.
Smith & Nephew Joins List of VERASENSE™ Partners
Smith & Nephew which has signed an agreement with OrthoSensor that will pair the company’s VERASENSE Sensor Assisted Surgery Technology for soft tissue balancing with Smith & Nephew’s JOURNEY™ II and LEGION™ Total Knee Systems.
AngioDynamics sees FDA Clear BioFlo DuraMax Hemodialysis Catheter and Takes Control of Celerity System
Quite a time for AngioDynamics. First the company gets news that another iteration of its successful BioFlo platform has gained FDA’s nod. Then, its distribution partner Medcomp gets the FDA’s knock-back over its 510(k) submission for the Celerity tip location system, leading AngioDynamics to take over the regulatory reigns there too.
New Drug Delivery Device Company, Medallion Therapeutics Emerges from Alfred Mann Foundation
An implantable drug delivery pump forms the basis of a new company, Medallion Therapeutics, Inc., which has sprung from the Alfred Mann Foundation (AMF) for Scientific Research.
“Enlightened” Investors Support Invuity’s $36 Million Financing Round
Invuity’s clever delivery of lighting to even the most awkward surgical site is clearly winning surgeon fans, the company’s sales having doubled last year. Now a new successful funding round will enable it to accelerate its activities.
First 4F MR Conditional CRT Lead CE Marked and In Use
Frequent visitor to our pages, cardiovascular device company Biotronik has announced the first implantations of the Sentus ProMRI® lead.
Cook’s Venous Stent Study Sees First Ten Patients
Cook Medical has updated us with news that the first ten patients in its VIVO venous stent study have been treated with the Zilver Vena stent.