Showing all posts written by Tammi Hill

Tammi Hill

BDC Laboratories Announces VDT-3600i Heart Valve Accelerated Wear Test System

Biomedical Device Consultants and Laboratories (BDC Laboratories) announced today that its VDT-3600i Accelerated Wear Testing (AWT) system for heart valves allows evaluation of chronic wear in valve leaflets in a predictable, controlled, and reproducible manner.  The press release states that the AWT system demonstrates how a device may perform throughout its chronic use in vivo to support research and development efforts, for example, with respect to the emerging transcatheter aortic valve implantation and minimally invasive mitral valve replacement fields.

According to the press release, positive clinical outcomes continue to be reported by researchers studying transcatheter aortic valve implantation using the AWT system.  BDC Laboratories states that it provides innovative and advanced product offerings to support medical device companies in evaluating their next-generation implants.

BDC Laboratories’ press release is available here.

OrbusNeich Sues Boston Scientific In Ireland

OrbusNeich Sues Boston Scientific In Ireland

OrbusNeich Medical Inc. and its subsidiary, Orbus International B.V., announced on Friday a lawsuit against Boston Scientific Corp. in Ireland for alleged patent infringement.  According to the press release, the lawsuit alleges that Boston Scientific’s coronary stent systems, including the PROMUS Element™, PROMUS Element Plus™, OMEGA™, TAXUS™, SYNERGY™, and Promus PREMIER™ lines of stents, infringe European Patent No. 2,311,412 and European Patent No. 1,341,482, both entitled “Stent having helical elements,” granted on August 9, 2012 and September 23, 2010, respectively.  Figure 11 from the ‘412 patent is shown below:

In February, OrbusNeich filed suit against Boston Scientific for patent infringement in Germany and the Netherlands.  A patent infringement suit filed by OrbusNeich against Boston Scientific in the U.S. in 2009 was stayed pending reexamination of the patents by the U.S. Patent and Trademark Office.  The asserted European patents are available at EP 2,311,412 and EP 1,341,482.

FDA Approves Wellaho Mobile Monitoring Platform

Sanitas, Inc., announced today that it received approval from the United States Food and Drug Administration for its Wellaho system.  According to its press release, Wellaho’s Personalized Outpatient Management System™ has been approved as a 510(K) class II medical device.  The press release states that the Wellaho system is a web-based and mobile platform that allows providers a secure, HIPAA compliant tool to supervise and monitor patients with chronic conditions between office visits.

The CEO of Sanitas, Inc. states:

Patients with chronic conditions need a web of care, coming from the best that providers and technology can offer. Given the tsunami of new apps and technologies that hit the market each year, both patients and providers need the highest validation for the products and services they use. Now, with the FDA’s approval, Wellaho offers one more reason for providers and patients to trust that we can provide a safe, secure, and effective solution for managing their care.

According to the press release, the Wellaho system is currently deployed in clinical studies at UC San Diego Health Services.  Sanitas, Inc.’s press release is available through PRNewswire here.

J&J Expands Space for Startups

MedCityNews reports that Johnson & Johnson (J&J) recently added space to its San Diego innovation center, a shared laboratory space that gives startups access to lab space without having to commit to additional capital.   Startups rent the space and wet lab units they need on a short term basis and can expand when they have the ability to do so.

According to MedCityNews, the open plan design of the “concept lab” is designed to spark interaction between entrepreneurs and help J&J identify opportunities for investment:

Janssen Labs is part of a wider effort by J&J to enlist creative deal making strategies, to position itself to spot opportunities early.  It also helps make the medical device and big pharma business appear more welcoming to innovation and early stage companies, who face the daunting challenge of convincing private investors and companies to invest in their business.

J&J reportedly plans to open similar labs for startups in Boston, China and Europe, staffing the centers with experts who will identify early stage innovations.

Federal Circuit Upholds Lower Court Decision in Edwards Lifesciences v. CoreValve

Edwards Lifesciences succeeded in its appeal at the Federal Circuit in the lawsuit Edwards Lifesciences v. CoreValve.  Edwards’ lawsuit asserted that the Medtronic CoreValve ReValving system infringed U.S. Patent No. 5,411,552, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis”.

The Federal Circuit upheld the District Court’s decision in favor of Edwards Lifesciences and sent the case back to the District Court to reconsider its decision to deny an injunction.  The Federal Circuit’s decision is available here.