Companies

Boston Scientific has followed its July CE mark approval of the Promus Premier drug eluting stent, with a newly announced FDA approval. The company claims “next generation” status, based on enhancements in stent design and delivery system.

Sorin gets CE mark approval for Solo Smart,the evolution of Freedom Solo, a stentless and biological aortic valve with no synthetic material, proven outstanding hemodynamic and clinical performance.

Verasense™knee technology developer, OrthoSensor™, has partnered with Valtronic for the contract manufacture of the devices to satisfy its growing customer list. A first unit has been shipped under the agreement.

Ethicon Endo-Surgery, Inc. and Megadyne®, Inc have both issued press releases, confirming that they have entered into a collaboration agreement. The deal will see customers offered a contracting solution that incorporates the two companies’ combined product offerings, increasing choice and access to a broad energy portfolio.

CareFusion’s widely publicised acquisition of Vital Signs from GE healthcare will be the company’s eighth acquisition since 2010 and at $500 million looks a steal compared with what GE paid only five years ago.

Last month we noted the CE mark approval of Boston Scientific’s Lotus™ transcatheter heart valve, which was indicated for use in aortic valve patients for whom conventional surgery was a high risk option. Now the first two commercial implants of the Lotus Valve have taken place in a German hospital.

Boston Scientific’s FDA cleared and CE mark approved new embolectomy catheter features a proprietary shaft design that the company says enables better control In hard-to-navigate Vessels.

The US FDA has issued its highest category of of recall (Class I) for a variety of Medtronic Guidewires, due to the potential for their PTFE coating to part company with the core.

Medtronic, Inc. has announced that a German court has ordered the discontinuation, in its entirety, of a prior court ruling that prohibited the company from commercially marketing or selling the CoreValve® System in Germany since August 26, 2013.

December 11th sees the FDA’s Circulatory System Devices Panel meet to discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage Closure Technology.

Last week we shared some pretty fiery correspondence that was made public by ConMed shareholder Voce Capital. Ten days later we see a response from ConMed, which has been filed with the SEC as part of the company’s fiduciary duty.

Titan Spine has dedicated itself to understanding surface texture and its impact on implantable orthopaedic materials. The company’s lofty ambitions to see its technology driving a paradigm shift have been boosted by recent revenue figures showing rapid growth, coupled with a distribution deal with Ortho giant Biomet in Germany.

It seems OrthoSensor has the technological capability to make knee prosthesis manufacturers’ implants look really good. Now Zimmer has signed up with the company to co-market the Verasense system alongside its own knee systems.

Medtronic’s Lead Integrity Alert software is designed to detect implantable pacing lead failures better than impedance monitoring alone. Now the company has gained FDA approval for its system to be used in the detection of problems with other manufacturers’ leads, which opens up a further 12,000 case in the US alone.

It’s been thought for over a decade that use of the anteromedial(AM) portal in ACL reconstruction is the best way of achieving an anatomical femoral socket, compared with drilling it through the tibial tunnel. Mitek sports medicine is showcasing its new purpose-designed Rigidfix® arc which facilitates Rigidfix cross pin fixation using the AM approach.

Biotronik has seen its clever, electrospun coated stent gain CE mark approval for use in cases of acute coronary vessel perforation. The clever part lies in the electrospinning, which creates a single, integrated coating without the need to sandwich the stent.