Biotronik won European regulatory approval for its Passeo-18 Lux drug releasing balloon and the company is beginning commercial efforts in all CE Mark countries.
Biotronik
Biotronik inks VA deal
Biotronik said it inked a deal to provide cardiac rhythm management devices to the 8 million veterans served by the U.S. Veterans Affairs Dept.
The Berlin-based company makes cardiac resynchronization therapy defibrillators and endovascular medical devices.
FDA OKs Medtronic lead alert system for Boston Scientific, St. Jude Medical devices
Biotronik wins CE Mark for PK Papyrus coronary stent
Biotronik announced today that it won CE Mark approval in the European Union for its PK Papyrus coronary stent system.
The Papyrus device is approved for treating acute coronary artery perforation, and features an innovative “electrospun” membrane to increase flexibility by 58% over its competitors, according to a Biotronik company statement.
FDA win in hand, Biotronik launches new Ilesto cardiac implants
Biotronik is beginning the launch of its newly approved Ilesto line of thinner, smaller cardiac implants with the remotely monitored Ilesto DX platform, the company announced today.
Study: Remotely monitored heart patients live longer
Heart failure patients with implant-based remote monitoring die less frequently from any cause, according to Biotronik study results released at the European Society of Cardiology congress in Amsterdam.
FDA approves Biotronik’s “smaller, thinner” heart rhythm implants
German medical device maker Biotronik today touted FDA approval for its Ilesto 7 line of next-generation implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators.
The devices are smaller, thinner and lighter and the new Ilesto DX allows physicians to monitor atrial information and possibly diagnose previously undetected instance of atrial fibrillation.
Biotronik lands CE Mark for MRI-safe Iforia defibrillator
Biotronik said it’s planning a mid-year launch in Europe for its Iforia MRI-safe pacemaker now that EU regulators have given the device CE Mark approval.
The German medical device company said the Iforia is the world’s 1st ICD/CRT-D device using the DF4 connector to be approved for magnetic resonance imaging, according to a press release.
Premier strikes CRM deals with Medtronic, Boston Scientific, others
Group purchasing organization Premier Healthcare Alliance struck a deal with 4 major players in the cardiac device market for several cardiac rhythm management device portfolios.
Biotronik lands Euro approval for MRI-friendly heart implants
German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants.
The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world’s smallest implantable cardioverter-defibrillators, according to Biotronik.
Mixed review for Biotronik’s absorbable stent
German medical device maker Biotronik touted early findings from a 1st-in-man study of its Dreams absorbable drug-eluting stent, with researchers reporting a mixed bag of findings for the device.
The Dreams stent proved safe at 1 year following the procedure, but wasn’t up to par with some rival devices, researchers noted.