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February 6, 2017 

Tissue Oxygen Wearable Patch for Peripheral Arterial Disease (PAD)

Profusa and North Carolina State University’s ASSIST Center announced their partnership to develop an ultrathin flexible-patch reader worn on the skin for continuous wireless monitoring of tissue oxygen in patients undergoing treatment for peripheral artery disease (PAD). The project has been awarded a $1.5 million Phase II Small Business Innovation Research (SBIR) grant administered by the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). Combining Profusa’s tissue-integrated biosensor technology with ASSIST’s thin-film electronics know-how, the “bandage reader” will be a companion device to Profusa’s Lumee Oxygen Platform recently introduced in the EU for use by medical practitioners to continuously measure tissue oxygen levels in ischemic limbs before, during, and after PAD treatment.


See more information on Tissue Oxygen Wearable Patch on Meddevicetracker.


February 7, 2017 

First Patients in Japan Treated with Aorfix Endovascular Stent Graft

Lombard Medical announced that physicians in Japan have treated the first 15 patients using its new IntelliFlex LP Delivery System for the Aorfix Endovascular Stent Graft since launch on February 1, 2017. The Aorfix AAA Flexible Stent Graft System is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms. When placed within the aneurysm, the Aorfix AAA Flexible Stent Graft System creates an internal bypass of the aneurysm to reduce the risk of rupture. The IntelliFlex LP is the next generation delivery system which the company says features a low profile replacement to the current platform. The company says it also includes a number of design improvements that provide the physician with improved control of pop-in deployment.

Aorfix with IntelliFlex is exclusively distributed in Japan by Medico’s Hirata, one of the country’s leading suppliers of vascular products with proven expertise in building significant market share for AAA stent grafts.


See more information on Aorfix Endovascular Stent Graft on Meddevicetracker.

February 8, 2017 

Veracyte and Quest Diagnostics Partner to Distribute Afirma

Veracyte announced it will extend access to its Afirma Gene Expression Classifier (GEC) through an agreement with Quest Diagnostics. The agreement is intended to meet growing physician demand for innovative genomic testing services to improve thyroid cancer diagnosis. Thirty-percent of patients who are evaluated for potentially cancerous thyroid nodules in the US each year receive an indeterminate result. Following surgery, about 80 percent of cases prove to be benign, meaning the surgery was unnecessary. Veracyte's Afirma Test is a laboratory developed test to determine if thyroid nodules are cancerous through fine needle aspiration (FNA) biopsies.

Veracyte currently makes the Afirma GEC available to physicians at institutions and community-practice settings throughout the country. Quest Diagnostic serves approximately half the physicians and hospitals in the United States. 


See more information on Afirma on Meddevicetracker.

February 9, 2017 

Pivotal Study Data announced for Vbloc Therapy Device

EnteroMedics announced that data from the Pivotal VBLOC DM2 study were published in the Journal of Diabetes and Obesity in the article entitled "Vagal Nerve Block for Improvements in Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study." The study aimed to assess safety and changes in weight, glycemic parameters and other risk factors with vBloc therapy, also known as the Maestro Rechargeable System.

After three years of therapy, mean percentage of excess weight loss was 21% (95% CI, 14 to 28) or 7% total body weight loss (95% CI, 5 to 9). Hemoglobin A1c decreased by a mean of 0.6 percentage points (95% CI, 0.2 to 1.0) from a baseline of 7.8%. Fasting plasma glucose declined by a mean of 18 mg/dL (95% CI, 2 to 34) from a baseline of 151 mg/dL. 71% of study participants were at or below the American Diabetes Association target for HbA1c for people with diabetes of 7%.


See more information on Maestro Rechargeable System on Meddevicetracker.


IN.PACT Admiral DCB Receives Health Canada Approval

The IN.PACT Admiral Drug-Coated Balloon received Health Canada license as a primary endovascular device used in patients with peripheral arterial disease (PAD) I the upper leg, specifically in the high (superficial femoral arteries) and behind the knee (popliteal arteries).

The IN.PACT Admiral DCB is an over-the-wire balloon catheter with a drug coated balloon at the distal tip. What distinguishes the IN.PACT Admiral DCB from other alternatives for PAD is the coating formulation, composed of a proven anti-proliferative drug (paclitaxel) and an excipient (urea). Once inflated, the coating comes into contact with water in the bloodstream, which hydrates the urea, facilitating the release of solid-phase paclitaxel to the vessel wall to help prevent restenosis.


See more information on IN.PACT Admiral on Meddevicetracker.

February 10, 2017 

CorPath GRX System Launches in the United States

Corindus Vascular announced that the first commercial procedures have been performed using its CorPath GRX System following the company’s recent 510(k) clearance from the U.S. Food and Drug Administration (FDA). In early February, NewYork-Presbyterian, UC San Diego Health, and University of Virginia Health System used the CorPath GRX System to perform robotic-assisted PCI procedures. Corindus began limited installations of the CorPath GRX System in January 2017 with plans for a full commercial launch in late February. The CorPath System is intended for use by physicians in tile delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures. The CorPath System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.


See more information on CorPath Vascular Robotic System on Meddevicetracker.

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