Boston Scientific launches Captivator EMR device

Boston Scientific (NYSE:BSX) said today it launched the Captivator endoscopic mucosal resection device designed as a minimally-invasive alternative to esophagectomy procedures.

The Captivator allows for staging and removal of precancerous tissue and early esophageal cancer in the upper gastrointestinal tract, the Marlborough, Mass.-based company said.

The device gives operating physicians a 360 degree view of the esophagus and can be used with accessory devices that can be used to “manage potential complications quickly,” the company said.

“The Captivator EMR Device provides improved endoscopic visualization, so the resection can be better directed to the area of interest. The enhanced view, along with easy passage of accessory devices and the ability to use compatible hemostatic devices to manage potential bleeding and complications may enable a safer endoscopic resection,” lead investigator Dr. Jacques Bergman of the University of Amsterdam said in a press release.

Endoscopic management could help reduce the need for invasiveesophagectomy in patients with Barrett’s Esophagus, a complication of acid reflux disease and a common precursor to esophageal cancer, the company said.

“As a leader in GI endoscopic devices, this launch complements our existing product offering for lower GI EMR procedures, and expands our portfolio into the growing upper GI EMR segment. The Captivator EMR Device provides physicians and patients with an important new option for staging and treating early esophageal neoplasia and cancer,” endoscopy prez David Pierce said in prepared remarks.

Boston Scientific said it enrolled the 1st patient in a multi-center, prospective post-market registry to study the performance of the device when used for endoscopic resectioning of abnormal tissue growth, known as neoplasia. The study is slated to enroll 300 patients at 16 centers across 8 countries, with a tentative completion some time in 2016.

The device is cleared and available in the U.S., Europe, Singapore, Australia and Puerto Rico, the company said.

The post Boston Scientific launches Captivator EMR device appeared first on MassDevice.

from MassDevice http://ift.tt/1iIvJmE

Fractyl Labs touts data from Revita study

Fractyl Labs said yesterday that a study of its Revita duodenal mucosal resurfacing system reported significant changes in blood sugar in type 2 diabetes patients, similar to those seen with bariatric surgery procedures.

Data from the study was presented at the 3rd World Congress on Interventional Therapies for Type 2 Diabetes in London this week, Waltham, Mass.-based Fractyl said.

The Revita device is designed to ablate the duodenum (the 1st part of the intestine) in order to alter glucose metabolism. Fractyl calls its approach the “1st procedural therapy to treat type 2 diabetes.”

“I appreciate having the opportunity to present our data. Patients in this study had poorly controlled type 2 diabetes, despite medication use. They experienced a significant improvement in HbA1c after this minimally invasive procedure, as well as some weight loss. With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes pathology, and that altering it can meaningfully improve blood sugar control,” Dr. Alan Cherrington of Vanderbilt University said in a press release.

The 39-patient proof-of-concept study had primary endpoints of patient safety and reduction in HbA1c after 6 months, and examined patients with “poorly controlled” type 2 diabetes. Patients were treated with either a long-segment or short-segment DMR procedure.

The study reported that patients treated with the long-segment treatment showed better improvement in baseline HbA1c at 3-months post procedure compared to those treated with short-segment DMR. Patients in the long-segment DMR cohort reported a decrease in HbA1c from 8.5% to 7.1% and a 5 lb reduction in weight. The company said there was no apparent correlation between weight loss and HbA1c improvement.

“Earlier this month, our team published a 5-year follow-up study showing that surgery may be more effective than standard medical treatments for the long-term control of type 2 diabetes in obese patients. This is a huge shift in how we think about the disease. It will be exciting to see if these early results using a much less invasive duodenal mucosal resurfacing approach will be reproduced in larger studies,” Dr. Francesco Rubino of King’s College in London said in prepared remarks.

Three patients experienced duodenal stenosis that required endoscopic balloon dilation, but did not result in serious adverse events.

“These results are helpful as we design our path to market, including pivotal trials in Europe and the United States. It is exciting to have our data presented at WCITT2D in context of the spectrum of novel intervention therapies for type 2 diabetes,” CEO Dr. Harith Rajagopalan said in a prepared statement.

In July, Fractyl said it enrolled the 1st patients in a separate trial of its Revita duodenal mucosal resurfacing system designed to treat the digestive causes of insulin resistance in patients with type 2 diabetes.

More than 10 patients have been enrolled and treated in the 1st phase of the Revita-1 study, which is slated to enroll 50 patients across 10 sites. The study seeks to explore changes in HbA1c in patients with diabetes who have poor glucose control on oral medications, Fractyl said.

The post Fractyl Labs touts data from Revita study appeared first on MassDevice.

from MassDevice http://ift.tt/1KIIE1L

Stentys wins CE Mark for BTK drug-eluting stent

Stentys SA (EPA:STNT) said yesterday it won CE Mark approval in the European Union for its drug-eluting stent for treatments of below-the-knee arteries.

The self-expanding, drug-eluting stent is the 1st of its kind with regulatory approval in Europe for BTK arteries, according to the French company.

“Entering the peripheral arterial disease market, which, outside of the U.S. and Japan, is estimated at $1.3 billion, represents a significant long term growth opportunity for Stentys. Now that the product is CE Marked, becoming the 1st stent that combines the benefits of self-expansion and drug-elution in this indication in Europe, we intend to formalize new distribution partnerships and expect to begin commercializing the product in 2016,” CEO Gonzague Issenmann said in prepared remarks.

The CE Mark was obtained based on results from the company’s PES BTK-70 study, which reported a 99% prevention rate of foot amputation in the 70 patients treated with the device for critical limb ischemia.

In April, Stentys said it won a CE Mark ahead of schedule for its self-apposing Xposition S coronary stent, a product that will be used with delivery system technology it acquired last June.

The early European regulatory O.K. enabled Stentys to officially launch its Xposition S system at the EuroPCR conference in May, the company said.

The post Stentys wins CE Mark for BTK drug-eluting stent appeared first on MassDevice.

from MassDevice http://ift.tt/1VoZTrD

Study: Computer-aided mammograms fail to improve detection, raise costs

Computer-aided breast cancer screening technology designed to boost accuracy have failed to increase detection, according to a new study published yesterday in the journal JAMA Internal Medicine.

The technology, from companies like Hologic (NSDQ:HOLX) and iCad (NSDQ:ICAD) failed to improve detection of cancerous tumors, according to the report.

“We found no evidence that CAD applied to digital mammography in U.S. community practice improves screening mammography performance on any performance measure or in any subgroup of women. In fact, mammography sensitivity was decreased in the subset of radiologists who interpreted mammograms with and without CAD,” study authors said.

The 323,973-patient study looked at women who underwent digital mammography screenings, with or without computer assistance, to examine the difference that CAD provided.

The study reported that cancer was found at nearly the same rate with or without the computer assistance.

Despite manufacturers claiming the technology improved sensitivity to detection, investigators in the study wrote that the “reported ‘high sensitivities” of CAD from these studies did not translate to higher cancer detection rates in clincal practice.”

While the study did offer that CAD assisted mammography did bring benefits in time savings, the study authors argued that the added cost was not worth the value overall.

“In the era of choosing wisely and clear commitments to support technology that brings added value to the patient experience, while aggressively reducing waste and containing costs, CAD is a technology that does not seem to warrant added compensation beyond coverage of the mammographic examination. The results of our comprehensive study lend no support for continued reimbursement for CAD as a method to increase mammography performance or improve patient outcomes,” the study reported.

The post Study: Computer-aided mammograms fail to improve detection, raise costs appeared first on MassDevice.

from MassDevice http://ift.tt/1FAw8Cs

House advances reconciliation bill to dismantle Obamacare

The U.S. House of Representatives Committee on Ways and Means said yesterday it is advancing legislation targeting the Affordable Care Act with a provision to repeal the medical device tax.

The legislation will operate through a budget tool known as “reconciliation” which will allow the bill to pass through the senate with a simple majority vote. Previous bills looking to dismantle the act and repeal the device tax have failed to overcome the senate’s 60-vote threshold.

“The law is as unpopular as ever. Now is the time to use all the procedural tools at our disposal to directly challenge the president,” committee chair Paul Ryan said in a press release.

The committee said the tax was “increasing the cost of care, discouraging medical innovation, and costing good jobs,” and that taxes were limiting, instead of promoting, the discovery of new medical technology.

The reconciliation bill includes sections from 3 committees, including the Energy and Commerce Committee and the Committee on Education and the Workforce.

“This week, all 3 will pass their pieces of reconciliation and report them to the House Budget Committee. The Budget Committee will then stitch them together before sending 1 unified reconciliation bill to the floor for the full House to consider in the coming weeks,” the committee wrote.

The post House advances reconciliation bill to dismantle Obamacare appeared first on MassDevice.

from MassDevice http://ift.tt/1h7lVSi

Medtronic pays $500m restructuring charge

Medtronic (NYSE:MDT) said yesterday it underwent internal restructuring after its $50 billion merger with Covidien that resulted in a 1-time charge of approximately $500 million in income tax to the U.S, according to an SEC filing.

As a result, the company has freed up approximately $9.3 billion in assets previously held by U.S.-controlled subsidiaries that exist outside the country, according to the SEC filing.

Medtronic moved its legal domain from Fridley, Minn. to Ireland with the merger that closed in January.

“The restructuring provides Medtronic with additional financial flexibility and increased confidence in the company’s ability to meet its financial commitments, which include continuing to target an “A” credit profile through a reduction in its debt to EBITDA ratio by the end of fiscal year 2018, returning a minimum of 50% of its free cash flow to shareholders through dividends and share repurchases, and pursuing financially disciplined M&A,” the company said in the filing.

The company said that the restructring will not affect its previous fiscal 2016 revenue outlook or guidance.

Yesterday, Medtronic said it acquired Campbell, Calif.-based stent-retriever cover developer Lazarus Effect for $100 million in an all-cash transaction.

Lazarus’ Cover device is designed to wrap stent retriever devices with a novel nitinol “mesh cover” that folds over the retreiver during clot retrieval and “candy wraps” the stent with the clot contained, Fridely, Minn.-based Medtronic said.

The post Medtronic pays $500m restructuring charge appeared first on MassDevice.

from MassDevice http://ift.tt/1VkUhE6

Emergo Podcast: Mexico’s medical device registration process

By Stewart Eisenhart, Emergo Group

Emergo’s latest podcast covers medical device registration requirements for Mexico, Latin America’s second-largest device market behind Brazil.

In this podcast, Emergo International Operations Manager Katie Senechal, Business Development Manager Miguel Torres Tello and Senior Regulatory Affairs Specialist Constanza de la Garza—all based in our Mexico City office—explain several pertinent issues to consider when applying to COFEPRIS for market authorization in Mexico.

• Device classification rules
• Mexico Registration Holder (MRH) in-country representation
• Certified quality system requirements
• COFEPRIS registration and review timeframes
• Mexico registration modification processes

Additional information on device registration in Mexico is available via our Mexico whitepaper, registration overview video and regulatory process chart.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post Emergo Podcast: Mexico’s medical device registration process appeared first on MassDevice.

from MassDevice http://ift.tt/1QJumzj