|FDA Approves First ICD to be Evaluated in US Clinical Trials; Medifirst Seeks Expansion Into International Markets|
|By Staff and Wire Reports|
|Thursday, 13 March 2014 19:47|
BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced the FDA has approved the expansion of BIOTRONIK’s ongoing ProMRI® trial. The new phase of the trial (Phase C) will study the company’s ProMRI® technology in implantable cardioverter-defibrillator (ICD) devices. BIOTRONIK is the only company in the world with an ICD that is approved for investigational use in an MRI (magnetic resonance imaging) scanner. The ongoing ProMRI® study is the first step in making this standalone technology available in the United States.
“This technology will finally allow full diagnostic capabilities for our patients who are more likely to need MRI scans,” said Theofanie Mela, M.D., Director of Pacer and ICD Clinic at Massachusetts General Hospital in Boston. “MRI is a safe and reliable diagnostic technology, and demand for imaging studies is growing. ICD patients are frequently recommended for MRI scans, but until now they have been unable to receive them. We are very excited to be participating in the ProMRI trial.”
The first phase of the ProMRI® trial (Phase A) evaluated the safety of the BIOTRONIK Entovis pacemaker systems during MRI scans, excluding scans in the chest area. This phase was completed on November 18, 2013, and the FDA is now conducting its review of the Pre-Market application. Earlier that same month, the FDA had approved Phase B of the study, which expanded the trial to evaluate the safety of these pacemaker systems during MRI scans including cardiac and thoracic spine scans. Phase B has already enrolled more than 100 of the planned 245 patients, and will continue concurrently with the newly approved ICD phase of the study.
“In the last three months, the clinical study sites have completed half of the Phase B enrollments, and I expect that momentum to continue through Phase B and as we begin Phase C,” said Kevin Mitchell, Vice President, Clinical Studies at BIOTRONIK, Inc. “There is real enthusiasm to bring this meaningful advancement to patients; it’s very positive and palpable throughout the study sites.”
Every year, more than 300,000 people are implanted with ICD systems, and studies estimate that 50-75 percent of these patients will develop a clinical need for an MRI scan during their lifetime.1,2 MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT) or ultrasound. The strong forces applied during an MRI scan can have a negative effect on both device and patient, and are usually contraindicated for pacemaker and ICD patients. With its ProMRI® technology, BIOTRONIK has developed a solution that is designed to enable all cardiac rhythm patients access to MRI scanning. The ProMRI® technology is already widely used in EU countries.
The latest phase of the ProMRI® clinical study aims to determine whether ICD patients can safely undergo MRI scans with an exclusion zone. The study will recruit and evaluate 172 patients at 35 U.S. investigational centers. The ICD ProMRI® with exclusion zone study is designed to confirm the safety and efficacy of BIOTRONIK’s Iforia devices, with Setrox and Linoxsmart leads during an MRI scan. All the devices in the study are currently commercially available, but still await FDA approval for use in the MRI environment.
The Iforia platform is BIOTRONIK’s latest generation of ICDs offering uncompromised longevity and daily monitoring through BIOTRONIK Home Monitoring®. The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.
Medifirst Solutions, Inc. (OTCQB: MFST) would like to take this opportunity to update shareholders about its latest company developments. Stated CEO Bruce J. Schoengood, "Having just finished exhibiting at the IECSC show at the NYC Javits Center, we are very pleased with the initial results and all the business opportunities and new relationships that were made. We had the great pleasure to meet and introduce our products and technology to many spa, salon and wellness center owners from all over the country and many parts of the world. We look forward to following up and continuing our discussions and updating our shareholders on further developments from the show."
Here are some specific updates: Dr. Ron Rubin, the Medical Director of the Medifirst Boca Med Spa, has initiated discussions with a Supplier and Exporter from Kazakhstan. Her current product lines include medical supplies and high technology to Moscow distributors. Commented Dr. Rubin, "I mentioned that I practice Oral and Maxillofacial Surgery and that I recently expanded my services with Photonic light and Laser therapy enhanced with the use of Chinese herbs and Rain Forest botanicals.
The reason I chose 'The Time Machine Program' is that it is highly efficient, without poison tipped Botox needles, no injections, no pain, no redness and without incisions. The Exporter, came to our Boca Med Spa for a presentation and demonstration and was so impressed with the results and the system, that she agreed to present our systems to her contacts in Moscow and other counties where there is great demand for beauty, skincare and anti-aging products." Stated CEO Schoengood, "Theses discussions are in the early stages, but I am very confident that we have a golden opportunity to expand into the international arena with our products. We expect the discussions to be fast-tracked and I look forward to updating our shareholders on the progress of expanding to these markets."
Medifirst has been making steady progress on the legal marijuana front. After agreeing to verbal commitments, we are now entering the process of completing written agreements with industry professionals to join our new advisory board and take an active role for our legal marijuana division. We plan to announce the additional of a medical doctor, an attorney, and other industry leaders within the upcoming days and weeks. Stated Schoengood, "There is an explosive amount of interest in the business of and businesses related to legal marijuana and we plan on positioning Medifirst Solutions to get an early foothold in the industry."
Medifirst will also be announcing a new NJ corporate headquarters in the upcoming weeks. The company is looking at several locations and will make an announcement when a final decision is made. Medifirst currently offers its wellness services in its Boca Raton, FL and Morganville, NJ offices.
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