NMT Medical (Boston) said it has received approvals to initiate a multi-center clinical study in the United Kingdom to evaluate its new BioSTAR PFO (patent foramen ovale) closure technology. The BioSTAR Evaluation Study (BEST) will be the first in-human use of a bioresorbable collagen matrix incorporated on the company’s STARFlex platform.
Noting that the goal of the study is to secure European commercial approval for the BioSTAR technology through the CE mark process, NMT President and CEO John Ahern termed the approval of the BEST study “another important milestone for NMT and for our clinical researchers seeking better ways to treat their PFO patients.”
Michael Mullen, MD, interventional cardiologist at Royal Brompton Hospital (London) and chief investigator for the BEST trial, said, “Based on preclinical research results, we believe that BioSTAR potentially offers a more natural, rapid and complete sealing of atrial level heart defects such as PFO.”
He said that once delivered, BioSTAR creates a bioscaffold that promotes native tissue deposition. “During that process, the collagen matrix dissolves, leaving behind natural tissue that completely covers the STARFlex alloy framework.”
The preclinical research was conducted in Germany by Christian Jux, MD, of the University of Goettingen, and Peter Wohlsein, DVM, of the Institute of Pathology in the School of Veterinary Medicine at Hannover. NMT said additional research support was provided by researchers at Johns Hopkins School of Medicine (Baltimore).
Ahern said that NMT has developed numerous research and technology collaborations over the past few years that “are now evolving into new, improved PFO closure therapies.”
He said that BioSTAR, “which combines an advanced biomaterial and our well-established STARFlex delivery platform, [is] one important outcome of that ongoing innovation process.”
According to Ahern, BioSTAR has “remarkable characteristics.” The collagen matrix, he said, “has the potential to deliver and localize drugs, genes, cells and other materials that may further enhance PFO closure outcomes.” The BioSTAR implant to be evaluated in the BEST clinical study, for example, will incorporate an ionically bound heparin substrate that elutes over time.
“We believe this feature improves device hemacompatibility by minimizing protein deposition that could lead to thrombus formation, a potential drawback to all current PFO closure implants,” Ahern said.
NMT Medical is investigating the potential connection between PFOs and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). More than 16,000 PFOs have been closed worldwide with NMT’s technology.
‘More needs to be done’ in UK cancer services
UK Health Secretary Patricia Hewitt last month lauded the National Health Service (NHS) for its improvements in cancer services and in reducing waiting times for treatment, but warned that meeting two key targets for cancer waiting times must become a priority.
The NHS Cancer Plan, which was formulated in 2000, set out two targets for cancer waiting times, due to be met by December of this year. One calls for all patients diagnosed with cancer to begin treatment within a maximum of 31 days of the decision to treat, while the other states that all patients with cancer who have been “urgently referred” by their general practitioner should begin treatment within a maximum of 62 days of that referral.
The Department of Health said that preliminary data shows that some NHS trusts are not making the progress expected, citing data collection and waits for diagnostic tests as particular obstacles that must be overcome.
Speaking at the National Cancer Waits Project briefing in London, Hewitt said, “We are almost at the halfway point of implementing the NHS Cancer Plan and looking back at the last five years there is a clear . . . story of real improvement. We are better at preventing cancer, better at detecting cancer, better at treating and curing cancer and better at caring for patients with cancer.”
However, she said, “a great deal more needs to be done. The 31- and 62-day targets have been achieved for breast cancer and we’ve clearly seen how they are benefitting patients. They are being achieved for other cancers in some parts of the country [but] they must be achieved for all cancer patients in all parts of the country.”
Noting that “these are not targets for the sake of targets, they are targets for the sake of patients,” Hewitt said redesigning services and introducing “new, creative and more efficient ways of working are essential if we are to continue improving the treatment and care of all NHS patients.”
The latest figures for breast cancer services, covering the period from December 2004 to March 2005, show that 96.2% of women urgently referred by their GP and who receive a positive diagnosis receive their first treatment within 62 days, while 97.8% of women receive treatment for breast cancer within 31 days of diagnosis.
Qiagen in agreement to buy Nextal Biotech
Qiagen (Venlo, the Netherlands) has entered into a definitive agreement to acquire Nextal Biotechnology (Montreal), a provider of sample preparation tools that make protein crystallization more accessible.
The deal calls for Qiagen to pay about $9.7 million in cash in exchange for all of the outstanding stock of Nextal, with an additional consideration of some $4.5 million subject to certain milestones.
Nextal has developed and begun marketing of a suite of consumables that it said “dramatically simplify” the process of sample preparation of proteins for subsequent crystallographic analysis.
Qiagen is a leading global provider of technologies and products that enable the separation, purification and handling of nucleic acids and proteins.