A Medical Device Daily
Guidant (Indianapolis) said this week that its Xience V everolimus-eluting coronary stent system has been recommended for approval by its European Competent Authority.
The company also reported that it had completed the Conformity Assessment process and facility audit by its European Notified Body and that it expects to receive the CE mark certificate for the system within the next week to 10 days.
“This news is a significant step forward in bringing this next-generation therapy to physicians in Europe,“ said John Capek, PhD, president of Guidant's Vascular Intervention business. “We are pleased that we have arrived at this point in the European approval process much sooner than we had anticipated.“
Capek said the company is “ramping up manufacturing and building inventory to supply our ongoing clinical trials and to support the European launch of Xience V in the second quarter.“
The Xience system uses Guidant's Multi-Link Vision cobalt chromium coronary stent system, which it calls its most advanced system and which is available on the rapid-exchange platform the company said is preferred by physicians.
Guidant said the drug that coats the stent, everolimus, “has been shown to reduce tissue proliferation in the coronary vessels following stent implantation.“
The 1,380-patient SPIRIT III global clinical trial is evaluating the Xience V stent system in the U.S. and Japan. The randomized U.S. cohort, which Guidant said would support U.S. premarket approval submission, has enrolled more than 70% of the required patients, with enrollment expected to be completed later this quarter.
Aurora breast MRI is approved
Aurora Imaging Technology (North Andover, Massachusetts), manufacturer of the Aurora 1.5T Dedicated Breast MRI System, said it has achieved CE marking and quality system certifications for the device, as well as Canadian approval of the system.
The Aurora System with Bilateral RODEO (Rotating Delivery of Excitation Off-Resonance) is designed to be located within breast care centers. The company said the system “is ideal for a wide range of indications in breast disease management,“ including:
- Detection of cancer in higher-risk women, especially those with dense breast tissue or for whom mammography is technically limited due to anatomic factors, such as surgical alteration or implants.
- Determining the extent of cancer for better treatment planning.
- Evaluation of patients to determine if there are positive surgical margins indicating residual cancer.
- Monitoring cancer response in patients being given neoadjuvant chemotherapy.
- Evaluation of breast implant integrity.
The company said the RODEO technology “suppresses fat and normal ductal tissue, [combining] easily with silicone-suppression sequences, allowing both implant integrity assessment and cancer detection in both breasts in a single MRI examination.“
“With a growing international demand for a complete breast MRI solution, we have many partners awaiting this certification,“ said President and CEO Olivia Cheng. Adding that centers without the Aurora system “provide breast MRI on traditional whole-body scanners that require accessory products from a variety of manufacturers that are poorly interfaced and often difficult to use,“ she said, “breast radiologists now have a truly integrated breast MRI solution.“
Hewitt cites NHS challenges
In a speech earlier this month, UK Health Secretary Patricia Hewitt set out the key challenges for the National Health Service (NHS) for 2006, saying it will be a “key year of transition“ for the NHS.
“We have to keep on delivering improvements for patients; we must restore financial balance in order to get the best value from the investment we are making; and we have to embed the reforms as we move towards a patient-led NHS,“ she said.
Hewitt added: “The NHS has improved dramatically since the 1980s and early 1990s. We are building more hospitals than ever before, improving long-neglected services like mental health, treating more people than ever before, and reforming the way we work at the same time as increasing investment.“
But, she said, “now is the time to increase the pace of reform and to widen the scope of our ambition – because we are within sight of an NHS where patients' demands and aspirations will be the key driver towards better, faster care and greater efficiency and value for money.“
Hewitt outlined four main elements to NHS reform:
- More choice and a “much stronger“ voice for patients, with patients' new rights to choose between hospitals “transforming the way local services respond to the public.“
- Money following patients, rewarding the most efficient providers and giving the rest a real incentive to improve.
- More diverse providers, with more freedom to innovate.
- A framework of regulation and decision-making that “guarantees quality, fairness, equity and value for money.“