A Medical Device Daily
Mitralign (Tewksbury, Massachusetts) reported that the first two implants of the Mitralign Percutaneous Annuloplasty System for mitral valve repair in its European pilot study have been performed by Drs. Eberhard Grube and Lutz Buellesfeld at Helios Heart Center (Siegburg, Germany).
The cardiac surgeons, who were assisted by Ralf M ller, MD, said the Mitralign system was able to "significantly reduce" the patient's mitral regurgitation.
The company said the Percutaneous Annuloplasty System "emulates suture mitral annuloplasty surgery without the risk and downside of open-heart surgery."
The implant was percutaneously delivered though a single 14 Fr femoral arterial sheath, and provided direct geometric reduction of the posterior annulus.
Grube said, "I was pleased with our ability to navigate in the left ventricle and to see mitral valve regurgitation reduced real time with 2-D and 3-D echo."
Mitral valve regurgitation (MR), is common in patients with congestive heart failure (CHF). Mitralign said clinical studies have proven that MR "significantly increases the risk of mortality in patients afflicted with CHF, a disease affecting 25 million worldwide."
Mitralign said it is "combining surgical precision with interventional therapy" in developing its catheter-based method to treat mitral regurgitation. The company said its goal "is to emulate the technique employed in traditional open-heart surgery, but in a far less-invasive manner."
EMEA in 'positive' responses to Neoprobe
Neoprobe (Dublin, Ohio) reported that the European Medicines Agency (EMEA; London) has provided positive formal responses to the company's scientific advice submission regarding RIGScan CR and the pathway to receive a marketing authorization for the drug.
Neoprobe asked the EMEA to review its manufacturing and clinical development plan for RIGScan CR. The EMEA concurred that Neoprobe could use updated and improved manufacturing processes to produce the antibody that is used in RIGScan CR and would be able to use all previously produced drug safety data derived from prior clinical studies to support a marketing authorization.
The company said the EMEA reviewed and agreed to the design and adequacy of a Phase III clinical study to be conducted in 380 patients with diagnosed primary or metastatic/recurrent colorectal cancer. The Phase III study would be a randomized trial with equal control and RIGScan CR treatment cohorts. The primary endpoint of the study would be improved survival for the RIGScan CR-treated patients as compared to the control arm.
Improved survival for the RIGScan CR treated patients was demonstrated in a retrospective survival analysis of patients in a prior RIGScan CR clinical study (NEO2-14) that was accepted by the EMEA.
In addition, the EMEA agreed to the clinical need for a product like RIGScan CR to improve the treatment of patients with colorectal cancer. And the EMEA also provided Neoprobe the opportunity to request a conditional marketing authorization (CMA) after completion of the initial antibody production or prospective clinical activities.
The opportunity for granting a CMA will be dependent upon the review of the supportive manufacturing and/or clinical information.
Neoprobe President/CEO David Bupp said, "The scientific advice response provides a clear, achievable development pathway for RIGScan CR. The response acknowledges that the technology meets a currently unmet medical need and has the potential for improving the long term prognosis for both primary and recurrent colorectal patients. The EMEA has suggested a mechanism for an early termination of the study if, as anticipated, early improved outcomes are observed in the RIGScan treatment arm versus the control arm patients."
Italian OTC approval for ActiPatch
BioElectronics (Frederick, Maryland), maker of the ActiPatch drug-free anti-inflammatory patch, said the company's products have received approval from the Italian Ministry of Health, allowing for over-the-counter sales throughout that country.
The company said its Italian distributor has placed additional restocking orders, "as sales of ActiPatch have continued to grow throughout the country."
ActiPatch features an embedded, battery-operated microchip that delivers continuous pulse therapy that BioElectronics says "revolutionizes the way people heal."
CEO/President Andrew Whelan said, "We are seeing very robust growth in our international retail markets and we are very pleased to add Italy to this list. This approval allows pharmacies throughout Italy to sell our ... products over the counter."
Alessio Petricca, director of marketing for the distributor, TSS Medical (Torino, Italy), added, "We are already seeing strong sales of ActiPatch, particularly in the northern part of the country. Approval from the Ministry of Health is significant and should add to this already robust growth rate."