Medtronic Issues First PMA Module for IN.PACT Balloon; St. Jude Announces Approval and First Use of Ablation Catheters Print E-mail
By Staff and Wire Reports   
Thursday, 15 August 2013 19:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 15, 2013.

Marking a major milestone in the advancement of new treatments for peripheral artery disease, Medtronic, Inc. (NYSE: MDT) announced the submission of its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon. Designed to treat atherosclerotic lesions in the superficial femoral artery (SFA), the novel angioplasty device remains investigational in the United States.

"Pending FDA approval, we remain on track to launch the IN.PACT Admiral drug-eluting balloon in the United States during the second half of calendar year 2015," said Tony Semedo, president of Medtronic's Endovascular Therapies business. "In the meantime, we will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology as an important addition to the treatment options for peripheral artery disease in the lower extremities."



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St. Jude Medical, Inc. (NYSE: STJ)
, a global medical device company, today announced U.S. FDA approval and first use of MediGuide Enabled™ Ablation Catheters. The ablation catheters, which are used to treat specific irregular heartbeats, expand the innovative MediGuide platform for St. Jude Medical.

The MediGuide Enabled ablation catheters can be visualized using 3-D magnetic tracking. MediGuide technology is the first and only system to potentially reduce the duration of radiation exposure during catheter ablation procedures. The catheters are used to create lesions (tiny scars) during cardiac ablation procedures to treat atrial flutter, a heart rhythm disorder where the upper chambers of the heart beat too fast and out of sync with the lower chambers. MediGuide sensors allow the catheters to be visualized and navigated in real-time on pre-recorded fluoroscopy.

“The availability of MediGuide ablation catheter tools allows us to effectively treat patients with ablation therapy using minimal exposure to radiation,” said Dr. Chun Hwang, Director Cardiac Electrophysiology, from Utah Valley Regional Medical Center in Provo, Utah, who performed the first procedure with the new ablation catheter. “We are exposed to radiation multiple times a day, which adds up quickly. Reducing the exposure time to radiation is a huge benefit for everyone in the EP lab.”

The Safire™ Duo and Cool Path™ Duo irrigated tip ablation catheters can now be visualized and navigated in real-time on pre-recorded fluoroscopy with MediGuide™ Technology. Featuring a high-performance tip with uni-directional or bi-directional deflection, these ablation catheters have the ability to be steered in two different directions for improved reach and maneuverability. They also include 12 irrigation ports for cooling tissue during procedures.

“The new MediGuide Enabled Ablation Catheters expand the utility of the MediGuide System, which is an important platform that provides clinicians with the ability to reduce the duration of radiation exposure and improve the accuracy and consistency of procedures. The MediGuide Technology is an example of our commitment to providing solutions for expensive and epidemic diseases that can have a direct impact on both physicians and patients,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.

The St. Jude Medical MediGuide technology provides a pioneering solution to better manage fluoroscopy exposure during Electrophysiology procedures. MediGuide Technology provides a comprehensive platform and set of tools to address a broad array of clinical applications including catheter ablations and CRT implants.

Worldwide, physicians perform several billion radiation-based imaging studies annually, approximately one-third of which are in cardiovascular patients. According to the American Heart Association, the collective dose of ionizing radiation that patients annually received during medical tests increased among the general population an estimated 600 percent between 1980 and 2006. As a result, there has been a dramatic increase in human exposure to ionizing radiation.



Also Thursday:



Adherex Technologies Inc. (TSX:AHX) (OTCQB:ADHXF) announced today that David Lieberman has resigned from the Board of Directors. Rosty Raykov, CEO and a director of Adherex, will assume the role of Chairman of the Board of Directors. Robert Andrade has resigned as Chief Financial Officer and a director of the Company.

Advanced Medical Isotope Corporation (OTCBB:ADMD)
, a company engaged in the production and distribution of medical isotopes, will host a teleconference to discuss its second quarter financial results and to provide a business update.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that its Board of Directors has declared a one-half percent stock dividend payable on September 13, 2013, to stockholders of record on August 30, 2013.

Bio-Path Holdings, Inc., (OTCQX: BPTH)
, a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced operational and financial results for the second quarter ended June 30, 2013.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX)
, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today the appointment of Laureen DeBuono to the company's board of directors.  Ms. DeBuono will also serve as a member of the company's audit committee.

Data published in The Lancet showed that elderly people with type 2 diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (TRADJENTA®), marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY), experienced significant reductions in blood glucose levels (HbA1c) compared with those receiving placebo.

Exlites Holdings International, Inc. (PINKSHEETS: EXHI)
announced today that it is in negotiations with China based medical equipment manufacturers regarding a partnership that allows the company to offer high-tech medical equipment to its customers at cost effective prices.

Medistem, Inc. (PINKSHEETS: MEDS)
, announced today the publication of a patent application entitled "Therapeutic Immune Modulation by Stem Cell Secreted Exosomes."

MediSwipe Inc. (OTCBB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry today announced that the Company has signed an exclusive license and formed a joint alliance with The Medical Cannabis Network to operate, market and administrate the premier online physician and patient registry www.MarijuanaDoctors.com.

MMRGlobal, Inc. (OTCQB: MMRF)
, a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that it has filed its quarterly report on Form 10-Q for the second quarter ended June 30, 2013 with the United States Securities and Exchange Commission.

MYOS Corporation (OTCBB: MYOS)
, a company focused on the discovery, development and commercialization of therapeutic and dietary products that improve human muscle health and performance, today announced that it will collaborate with Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, to conduct a pre-clinical study of the effects of myostatin inhibition by orally administered MYO-T12® on muscle tissue and body composition in conjunction with testosterone treatment.

Stock Market Media Group, a research and content development investor relations firm, issued its Third Quarter Update and the first installment of its Nuvilex, Inc. (OTCQB: NVLX): Road to Phase III Clinical Trials Report today.

The OTC Journal, the longest running electronic newsletter focused on the small cap and microcap sectors, wishes to provide accurate information on Nuvilex's (OTCQB: NVLX) unique live-cell encapsulation technology and its use in developing disease treatments.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce the expansion and relocation of the Company's UK office.

Promap Corporation (OTCBB: PMAP) announced today the acquisition of Advanced Cannabis Solutions, Inc. (ACS), a privately owned Colorado-based company that plans to become a national leader in the rapidly emerging, regulated marijuana industry.

SEI (NASDAQ: SEIC)
today announced the appointment of Craig Standen as Director of Healthcare Advisory Services for SEI's Institutional Group. Craig will oversee investment strategy development and advice for SEI's institutional healthcare clients.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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