A Medical Device Daily
NMT Medical (Boston) reported receiving CE-mark approval in Europe for its BioSTAR bioabsorbable septal repair implant technology and Rapid Transport delivery system.
President and CEO John Ahern said, “Receiving CE-mark approval for BioSTAR in Europe is an important achievement for NMT and we are enthusiastic about the potential impact of our bioabsorbable implants. BioSTAR also recently received Canadian regulatory approval and we anticipate initiating a market launch for BioSTAR in both Europe and Canada early in the third quarter.”
He added that BioSTAR has been approved for use in MIST II, the company’s pivotal patent foramen ovale (PFO)/migraine trial in the U.S.
BioSTAR is designed to provide biological closure of atrial level defects using the patient’s natural healing response. NMT said data has shown that 90% to 95% of the implant is absorbed over time and replaced with healthy native tissue. It said the data from the prospective multi-center BEST (BioSTAR Evaluation STudy) trial, published in the October 2006 edition of the journal Circulation, demonstrated that BioSTAR provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months.
“BioSTAR represents the first implant in a new generation of bioabsorbable technologies that NMT is developing in order to improve the treatment of structural heart disease,” said Ahern. “As demonstrated by the BEST clinical trial, we believe the unique biomaterial, drug and device combination used in BioSTAR enhances positive septal closure outcomes.
The BioSTAR bioabsorbable septal repair implant will be offered in three sizes: 23 mm, 28 mm and 32 mm. Equipped with the Rapid Transport delivery system, the average procedure time to close a septal defect with BioSTAR is about 40 minutes.
BioSTAR incorporates a purified acellular collagen matrix delivered on the company’s STARFlex alloy framework. The collagen used in BioSTAR also is a platform for timed release of biological response modifiers such as genes, cells, proteins and drugs.
An elutable heparin substrate has been included in the BioSTAR design, which the company said “provides a means to minimize the thrombus formation that occasionally occurs in all intra-cardiac devices.”
CoolMax catheter receives CE mark
Urologix (Minneapolis) said it has received the CE mark for its CoolMax Microwave Catheter. The company said the new catheter “is expected to allow doctors to more comfortably treat men who suffer from the symptoms of benign prostatic hyperplasia, a condition that affects some 23 million men.”
The CoolMax microwave catheter builds upon the company’s existing product portfolio and technology platform. It features the Urologix gamma matched dipole antenna design and features the addition of an enlarged cooling balloon.
The company said this next-generation catheter is part of an ongoing program intended to blend patient comfort with durability. Urologix said it next plans to enter into discussions with the FDA to seek U.S. approval for the device.
Fred Parks, chairman and CEO, said, “This release signifies our belief that the CoolMax catheter will meet our expectations of improved comfort over our current offering while maintaining the high level of durable outcomes our customers have come to expect from using our products.”
BreastCheck Ireland selects Bioptics
Bioptics (Tucson, Arizona) said it has been awarded a contract by BreastCheck Ireland, that country’s national breast screening program, along with its local distributor, DAAX. Bioptics and DAAX have been selected exclusively to provide digital specimen radiography equipment to BreastCheck clinics throughout Ireland.
Bioptics’ piXarray line of FDA-cleared Digital Specimen Radiography products are marketed worldwide and provide digital specimen imaging of both surgical and core biopsies. The company said its system “dramatically improves efficiency by providing full PACS networking, allowing surgeons, radiologists and pathologists the opportunity to digitally analyze suspected breast tissue on a real-time basis while the patient is on the operating table.”
“BreastCheck Ireland’s initiative is one of the most impressive in the world and we are excited to be a part of their pioneering efforts,” said Emre Toker, founder of Bioptics.
Poster cites Microcyn’s effectiveness
Oculus Innovative Sciences (Petaluma, California) said that its Microcyn technology was the subject of a poster presentation at the recent European Wound Management Association conference in Glasgow, Scotland.
The poster, titled “Clinical Results About an Antimicrobial Solution in the Treatment of Infected Chronic Wounds,” used Cutting & Harding infection criteria to evaluate the performance of the Microcyn technology plus antibiotics vs. a control group of povidone iodine plus antibiotics.
Forty patients with infected wounds were randomized into the two groups; 20 each in the Microcyn and povidone iodine groups. Analyzed data included: pain, improvement/resolution of the clinical signs of infection, bad-odor reduction, white blood cell count and duration of hospitalization.
The study, led by investigators from the operative unit of vulnology at the San Luca Clinic (Turin, Italy), concluded that the Microcyn technology showed better results than did the povidone iodine group in reduced number of days of hospitalization, reduction of clinical signs of infection and pain reduction.
LinkMed invests SEK 10 million in AnaMar
LinkMed (Stockholm, Sweden) reported that it is utilizing an option to make follow-up investments of SEK 10 million ($1.47 million) in each of two portfolio companies, AnaMar Medical (Gteborg, Sweden) and IMED (Stockholm).
LinkMed will be utilizing its AnaMar Medical option to subscribe to shares for SEK 7.5 million and has also has decided to invest an additional SEK 2.5 million in share capital. Both investments will be made in August.
AnaMar Medical’s other principal shareholder, Koncentra Holding, has promised to contribute a further SEK 2.5 million in share capital.
The moves are meant to expand AnaMar’s development “with both additional and further advanced development projects,” LinkMed said.