Companies

With EuroPCR* taking place any day, now seems a good time for companies to be previewing their offerings and debuting … continue reading “St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement”

St.Jude Medical Inc has issued a press release, telling us that Population Health Research Institute analysis continues to demonstrate strong safety and reliability of Optim-insulated leads. The data was presented at Heart Rhythm 2013 last week.

Sorin’s next-generation implantable defibrillators can now be monitored remotely using the company’s Smartview technology which has now gained FDA approval.

Stent company Biosensors International has entered into an agreement to acquire the assets of nuclear imaging company Spectrum Dynamics, a leader in advanced functional assessment technologies, including those used to evaluate patients for cardiac interventions. The move signals Biosensors developing an integrated approach to cardiac patient care.

In short Orthofix International N.V. has announced its results for the first quarter ended March 31, 2013. Net sales were … continue reading “Orthofix International Q1 14% Sales Decline”

Revenue for the quarter to end March increased by 33% over prior year, reflecting the impact of several new marketing initiatives leveraging positive validation from the MASTER I trial of the Company’s MGuard™ Embolic Protection Stent (EPS™).

The FDA has issued a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.

St. Jude Medical, Inc. has announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Mitek Sports Medicine has unveiled the Healix 3.4mm Suture Anchor, its smallest dual-thread offering for rotator cuff repair. This coincides with the introduction of a new double-loaded minimally invasive partial thickness rotator cuff repair system, as part of its Healix Transtend™ Implant System.

A first-in-human clinical trial using Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter for the treatment of type 1 atrial flutter has been completed in Australia.

Covidien and Mallinckrodt will go their separate ways shortly as the division sees itself turning into a publicly traded specialty pharma business. Strong pharma sales presage the event (as do declining sales in its imaging products).

Two new devices from the Medtronic ICD/CRT-D stable have gained FDA’s approval. These are the Viva®portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).

J&J division, Sedasys says its sedation system is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal-to-moderate sedation in defined patient groups undergoing colonoscopy and esophagogastroduodenoscopy procedures.

Zimmer Holdings, Inc. has announced that it has acquired the business assets of West Chester, Pennsylvania-based Knee Creations, LLC. Zimmer says the acquisition enhances its product portfolio of knee treatments through the addition of Knee Creations’ Subchondroplasty® procedure.

Medtronic’s Urgent Medical Device Correction notification relating to the use of potential damage associated with its Deep Brain Stimulation (DBS) lead kits and dystonia therapy kits has now been classified by the FDA as a Class I Recall, its most serious category.

St. Jude Medical, Inc. has announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P). The device brings quadripolar lead technology to the pacemaker market for the first time.