A Medical Device Daily

Health Robotics (Bolzano, Italy) said it has signed an exclusive cooperation agreement for Grifols (Barcelona, Spain) to significantly contribute to its I.V. Room of the Future initiative with its Misterium clean room products and I.V. therapy and clinical nutrition knowledge and experience.

The agreement also includes the appointment of Grifols' scientific expert Oriol Prat as an additional member of Health Robotics' scientific advisory board.

“Grifols has designed and constructed more than 1.2 million square feet of clean rooms worldwide and managed more than 150 modular clean room installations at hospitals. After witnessing the outstanding combined results of the joint implementation of Misterium and i.v.Station at Vall d'Hebron University Hospital in Barcelona, I was convinced that global hospitals stand to greatly benefit from the synergies between the respective companies' experience, products, and services within the I.V. Room Technology sector,“ said Gaspar DeViedma, Health Robotics' executive VP.

Health Robotics supplies life-critical intravenous medication robots. Its solutions CytoCare (hazardous IVs), i.v.Station (non-hazardous IVs), i.v.Soft (manual compounding software), MEDarchiver (clinical information system), and TPNstation (totally-automated parenteral nutrition) have and will greatly contribute to ease hospitals' growing pressures to improve patient safety, increase throughput and contain costs, according to the company.

CRT could be cost-effective for symptomatic HF

Medtronic (Minneapolis) reported findings from an economic sub-study of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial published in the European Heart Journal demonstrating for the first time that cardiac resynchronization therapy (CRT) is cost-effective in mildly symptomatic heart failure (HF) patients.

The results of this analysis showed a €14,278 per quality adjusted life years (QALY) gained for CRT, compared to the commonly used European willingness to pay (WTP) threshold of €33,000 (£30,000) per QALY gained. Additionally, the analysis showed patients receiving CRT are estimated to gain almost one full life year (0.94) or 0.80 QALYs compared to the group not receiving CRT, at an additional cost of €11,455, over 10 years.

“While prior studies have proven the numerous benefits and cost-effectiveness of CRT in treating symptomatic heart failure patients, now for the first time, these data show that CRT not only helps keep less sick heart failure patients out of the hospital more, but it is also a more cost-effective treatment approach than many other therapeutic options currently available,“ said Cecilia Linde, MD, PhD, Karolinska University (Stockholm, Sweden). “We look forward to conducting additional analyses demonstrating the economic value of this treatment approach in a mildly symptomatic patient population.“

In this economic analysis of a subset of patients in the REVERSE trial, 262 European patients were randomized to receive CRT therapy or to have CRT therapy switched off for 24 months. An economic model was developed to predict the effect of CRT on life years, QALYs and costs over time periods up to 10 years. The economic analysis was based on clinical data that showed at 24 months a worsening of HF in 34% of patients who did not have CRT therapy, compared with 19% of patients who did receive CRT therapy. Additionally, the time to first HF hospitalization was significantly longer in the CRT-on than the CRT-off group.

The REVERSE trial, sponsored by Medtronic, is a large-scale, global, randomized, double-blind trial that demonstrated the benefits of CRT in improving the function of the heart, including reduction in heart size and improvements in pumping efficiency, in certain asymptomatic or mild HF patients. CRT uses a stop-watch sized implantable device to resynchronize the contractions of the ventricles by sending tiny electrical impulses to the heart muscle. Resynchronizing the contractions of the ventricles may help the heart pump blood throughout the body more efficiently and reduce symptoms.

Twelve and 24-month REVERSE data have been published in peer reviewed journals. The trial did not meet statistical significance for its primary endpoint (percent of patients worsened at 12 months using a HF clinical composite score). However, patients experienced a significant improvement in cardiac function and reduction in HF hospitalizations. Furthermore, the European sub-group, which was followed through 24 months, demonstrated statistical significance for the same endpoint (19% versus 34% worsened in the CRT ON and OFF groups).

“Given its economic and clinical burden, heart failure is one of the most challenging problems currently plaguing the global healthcare system,“ said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior VP at Medtronic. “At Medtronic, we are dedicated to providing innovative and cost-effective solutions to meet these challenges. The valuable data uncovered by the REVERSE trial should move us closer to expanding the use of CRT, and our hope is that earlier intervention with this treatment will allow physicians to provide better and more cost-effective patient care to combat this serious and often debilitating condition.“

Covidien wins injunctions in Germany

Covidien (New Haven, Connecticut) said a Germany court awarded it preliminary injunctions against Panther Healthcare Medical Equipment (Beijing), WuXi Shenkang Medical Instrument Equipment (Yixing City, Jiangsu) and three other medical device companies that are accused of copying the design of Covidien's surgical stapling products and infringing a Covidien patent. Four of the device companies are based in China and one is based in the United Kingdom. In parallel procedures, German customs authorities have also seized accused infringing surgical stapling products from each of the five companies, Covidien noted.

“We are pleased that the German court and customs authorities have found that certain stapling products from these five companies should be removed from the German marketplace because of infringement of Covidien's patent. We will continue to vigorously protect our innovations and intellectual property,“ said Scott Herring, president of EMEA Surgical Devices at Covidien.