November's top stories: Grifols' $1.7bn acquistion, Sorin's approvals
Grifols announced a definitive agreement to acquire Novartis's blood transfusion diagnostics unit for $1.675bn, while Sorin obtained CE Mark approval for the Solo Smart stentless aortic valve. Medicaldevice-network.com wraps up the key headlines from November 2013.
Spanish company Grifols has announced a definitive agreement to acquire Novartis's blood transfusion diagnostics unit for $1.675bn.
The transaction will give critical mass and a significant US presence to Grifols's previously small diagnostics business, which in future is expected to account for more than 20% of the company's sales, compared with the current 4%.
The deal will be structured through Grifols's diagnostic division and a newly created 100% Grifols-owned subsidiary. It will also see an increase in Grifols' workforce by approximately 550 employees as former Novartis employees are likely to be retained.
Novo Nordisk has obtained US Food and Drug Administration (FDA) clearance for its prefilled insulin pens NovoRapid FlexTouch and Levemir FlexTouch.
FlexTouch is the only prefilled insulin pen that features an easy touch button and a spring-loaded mechanism.
The spring-loaded mechanism in the FlexTouch ensures that no matter how high the dose required, the push button does not extend and only a minimum of pressure is needed to deliver the dose.
Sorin Group has obtained CE Mark approval for its KORA 100 pacing system, a new magnetic resonance imaging (MRI) compatible pacing device.
The company also reported the first successful implant of KORA 100 pacing system at Landesklinikum St Pölten, Austria.
KORA 100 SR and DR pacemakers enable patients to undergo safe MRI scan when implanted with the Sorin BEFLEX pacing lead.
Boston Scientific has obtained US Food and Drug Administration (FDA) approval for the Promus Premier everolimus-eluting platinum chromium coronary stent system, the company's next-generation durable polymer drug-eluting stent (DES).
The Promus Premier stent system is designed to provide physicians improved DES performance in treating patients with coronary artery disease.
It is reportedly the only platform to feature a customised platinum chromium (PtCr) stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system.
Sorin Group has received CE Mark approval for the Solo Smart stentless aortic valve, a unique bioprosthesis designed to replace the aortic valve without leaving a stent in place.
According to the company, the Solo Smart device is the next version of its Freedom Solo replacement valve.
Introduced in Europe in 2004, Freedom Solo is a stentless biological aortic heart valve with no synthetic material and proven outstanding haemodynamic and clinical performance.
Boston Scientific has obtained US Food and Drug Administration (FDA) clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to embolise peripheral blood vessels in the treatment of conditions such as liver cancer or uterine fibroids.
Direxion torqueable microcatheter is designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature.
It will make it easier for interventional radiologists using peripheral embolisation to treat liver cancer, uterine fibroids and other challenging conditions.
CareFusion has signed a definitive agreement to acquire the vital signs division of GE Healthcare for $500m as part of its strategic plans to expand its respiratory care and anaesthesiology businesses.
The acquisition for the Vital Signs business in the US, China and other countries is expected to be closed by the end of December, with the full deal closing by 31 March 2014, pending regulatory approvals.
The acquisition of Vital Signs will mark CareFusion's eighth acquisition since 2010.
Germany-based Draeger is to launch its JM-105 jaundice meter in the UK; it is a new device for non-invasive transcutaneous bilirubinometer designed to identify at-risk infants as young as the 24 weeks gestational age.
The Draeger Jaundice meter JM-105 will be unveiled at the Annual Conference for the Royal College of Midwives.
While the readings are taken by gently pressing the sensor on the infants' forehead or sternum, all device functions can be controlled using a colour touchscreen.
Medtronic secured US Food and Drug Administration (FDA) approval for its first generation artificial pancreas system, while Stryker agreed to acquire Mako Surgical for $1.65bn.
Biotronik launched the new Ilesto implantable cardiac defibrillator, while St Jude Medical obtained CE Mark approval for a leadless pacemaker.