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May 5, 2015, 10:26 AM
- The FDA issues 510(k) clearance for Medtronic's (MDT -0.3%) Euphora Semicompliant Balloon Dilation Catheter, a pre-dilation therapy used during stent implantation to reopen a narrowed coronary artery caused by the buildup of plaque. The device helps physicians determine lesion characteristics, stent selection and facilitates stent access to the lesions.
- The U.S. commercial launch is underway.
May 4, 2015, 8:39 AM
- The FDA approves new indications for Medtronic's (NYSE:MDT) StealthStation electromagnetic (EM) surgical navigation system instruments for pediatric and adult cranial and ENT procedures. The clearance provides for additional neurosurgical applications that can benefit from flexible, tip-tracked instruments for both pinned and pin-less procedures. The navigated instruments can be used to aid in the placement of ventricular catheters, shunt systems, connection to Ommaya reservoirs, hematoma drainage, external ventricular drainage catheters, neuroendoscope peel-away catheters and depth-electrodes for epilepsy seizure monitoring.
- The StealthStation system is a proprietary tracking technology that utilizes unique engineering to generate an electromagnetic field around a patient's targeting anatomy, triangulating the position of instruments relative to patient-tracking devices during surgical navigation procedures. It is an aid to precisely locate anatomical structures in either open or percutaneous (through the skin) procedures.
Apr. 22, 2015, 10:38 AM
- The European Commission approves Medtronic's (MDT +0.2%) Activa portfolio of Deep Brain Stimulation (DBS) Therapy neurostimulators for MR Conditional full-body Magnetic Resonance Imaging (MRI). The clearance covers the ~13K people in Europe who are have already received a device in addition to future recipients.
- Previously, the DBS systems were cleared for MRI scans of the head only, under certain conditions. Also, they had to be turned off before the scan. Now, patients are able to continue receiving therapy during MRI scans. Many patients who are candidates for a DBS system have other conditions that frequently require MRI.
Apr. 14, 2015, 10:26 AM
- Medtronic (MDT -0.5%) receives CE Mark clearance for its Micra Transcatheter Pacing System, according to the company, the world's smallest pacemaker at one tenth the size of traditional pacers. Comparable to the size of a large vitamin, the Micra TPS is implanted directly into the heart via a catheter. It delivers electrical impulses through an electrode at the end of the device so it does not require leads.
- The retrievable system has a 10-year battery life and is approved for full-body MRI scans.
Apr. 13, 2015, 6:29 PM
- Looking to grab a bigger chunk of a burgeoning healthcare analytics market by offering more industry-specific solutions, IBM is buying Phytel, a provider of cloud-based patient data aggregation/analysis software, and Explorys, provider of a massive clinical database (said to consist of 315B datapoints) and a slew of analytics apps that run on top of them. Terms are undisclosed.
- IBM declares Phytel will help it give healthcare providers "insights into patient health from data about patient behaviors and their engagement with care plans," and that Explorys will "accelerate the delivery of IBM Health Cloud and IBM Watson cognitive solutions to model and apply medical evidence and large scale analytics to data."
- Both companies are being added to a new Watson Health unit based out of Boston. The business aims to provide software/services that can surface insights from large volumes of anonymous personal health data. As part of the effort, Big Blue is launching Watson Health Cloud, a platform that allows this data to be "anonymized, shared and combined with a dynamic and constantly-growing aggregated view of clinical, research and social health data."
- IBM's partnership with Apple (NASDAQ:AAPL) has been expanded to cover Apple's HealthKit (health/fitness data) and ResearchKit (medical research) frameworks, via Watson and Health Cloud. The latter will provide a data storage/aggregation platform for iOS apps using HealthKit and ResearchKit. In addition, IBM will "build a suite of enterprise wellness apps using HealthKit."
- Also: 1) IBM is partnering with Medtronic (NYSE:MDT) to create diabetes management solutions that pair Medtronic's devices (and the data they produce) with IBM's analytics and cognitive computing tools. 2) IBM is partnering with Johnson & Johnson (NYSE:JNJ) to "create intelligent coaching systems centered on preoperative and postoperative patient care, including joint replacement and spinal surgery."
Apr. 13, 2015, 10:20 AM
- The FDA designates ARCA biopharma's (ABIO +22.6%) lead product candidate, Gencaro (bucindolol HCl), for Fast Track review for the prevention of atrial fibrillation/atrial flutter in a genetically targeted heart failure population (those with reduced left ventricular ejection fraction). In a earlier sub-study of the BEST Phase 3 trial, patients with the combination of beta-1 389 and alpha-2C polymorphisms appeared to respond better to Gencaro.
- The company has identified common genetic variations that it believes will predict an individual patient's response to Gencaro, potentially making it the first genetically-targeted atrial defibrillation prevention treatment. It is currently being evaluated in a Phase 2b/3 study called GENETIC-AF, cosponsored by Medtronic (MDT +0.8%).
- Atrial defibrillation affects over 2.7M Americans, with as many as 500K new cases each year. Globally the number is greater than 33.5M.
- Fast Track status provides for more frequent access to the FDA review team and a rolling review of the New Drug Application (NDA).
Apr. 2, 2015, 10:59 AM
- Medtronic (MDT +0.4%) acquires Dutch clinic and research center Diabeter, a provider of comprehensive and individualized care for children and young adults with diabetes that currently manages over 1,500 type 1 patients. Terms are not disclosed.
- The buy marks Medtronic's first foray into a diabetes integrated care model. It intends work with Diabeter to further develop its model and then apply it around the world. It is pursuing similar strategies in heart failure and cardiology.
- Diabeter will operate as part of Medtronic's Diabetes Services & Solutions business unit.
Apr. 1, 2015, 12:30 PM
- Medtronic (MDT -2.1%) initiates a new clinical program, called SPYRAL HTN, to evaluate its next-generation renal denervation technology. It will begin with two global studies designed to address the issues in its earlier SYMPLICITY HTN-3 Phase 3 trial, which failed to achieve its primary and secondary efficacy endpoints.
- In the new studies, each enrolling 100 patients with moderate-to high-risk hypertension, physicians will use the company's Symplicity Spyral catheter and Symplicity G3 radiofrequency (RF) generator, both investigational in the U.S. and Japan. In SPYRAL HTN-OFF MED, the primary objective is to isolate the effect of renal denervation on blood pressure (BP) reduction. In SPYRAL HTN-ON MED, patients not achieving adequate BP control despite taking anti-hypertensive drugs will comprise the treatment group. Based on the successful outcomes of the two studies, the company will design a pivotal Phase 3 trial that will support regulatory applications in the U.S. and Japan.
- Renal denervation, using RF energy to ablate nerves in the wall of the renal artery, is an approved procedure to control resistant hypertension. Destroying the nerves in the artery interrupts the renal sympathetic nervous system and reduces BP. Its efficacy, though, has been questioned. About a year ago, Medtronic announced that SYMPLICITY HTN-3, failed to demonstrate efficacy compared to a sham control. The company believes that the trial design was the culprit, specifically the medication parameters, patient population and procedural variability. It believes that these issues will be corrected in the new trials.
Mar. 30, 2015, 5:03 PM
- The FDA approves a new indication for Medtronic's (NYSE:MDT) CoreValve System, a self-expanding device for aortic value replacement, to treat patients who have had a tissue aortic valve replacement and are in need of a second one, called "valve-in-valve" replacement.
- CoreValve is an artificial heart valve made from the heart of a pig. It is attached to a flexible, self-expanding nickel-titanium alloy frame and is placed in the heart via catheter. Once release by the end of the catheter, it expands automatically, anchoring itself to the old failed valve. Once in place, it expands and closes properly, restoring aortic valve function.
- The original indication was the treatment of patients with aortic stenosis (narrowing) who are considered "high" or "extreme" risk for surgical aortic valve replacement.
Mar. 30, 2015, 11:31 AM
- The Japanese Ministry of Health, Labour and Welfare approves Medtronic's (MDT +1%) CoreValve System for patients with severe aortic stenosis who are unable to undergo surgery. Aortic stenosis is a narrowing of the aortic valve which obstructs the flow of blood from the heart thereby making the heart work harder to pump blood.
- CoreValve is used in a procedure called transcatheter aortic valve implantation (TAVI). An artificial heart valve is inserted into the heart replacing the diseased aortic valve and restoring the size of the aortic opening.
- The CoreValve has a self-expanding frame which enables the doctor to place the device in a controlled manner thereby increasing the accuracy of placement. It was cleared in the E.U. in 2007 and in the U.S. in January 2014.
Mar. 27, 2015, 9:30 AM
- Medtronic (NYSE:MDT) completes its acquisition of privately-held Sophono, a developer of magnetic hearing implants. Terms are not disclosed. The business will be part of Medtronic's Surgical Technologies division within the Restorative Therapies Group segment.
- Sophono's magnetic bone conduction hearing implants have been placed in more than 4,000 patients in 42 countries. They are indicated for patients at least five years of age with single-sided deafness or conductive, mixed hearing loss.
- According to the World Health Organization, disabling hearing loss affects 360M people worldwide.
Mar. 18, 2015, 3:33 PM
- The FDA approves Medtronic's (MDT +1.6%) Protege GPS self-expanding peripheral stent system for the treatment of stenotic lesions in the common and external iliac (pelvic) arteries. The approval was based on clinical trial results that showed 95.8% nine-month primary patency (the interval between the placement of the stent and any intervention to reopen the blood vessel) and 98.6% freedom from target vessel revascularization (no repeat procedure).
- The Protege GPS, developed by Covidien, expands to a predetermined diameter to restore blood flow. It was previously cleared for use in superficial femoral (upper leg) and subclavian (upper chest) arteries.
Mar. 16, 2015, 7:44 AM
- Two-year results from the High Risk Study of the CoreValve U.S. pivotal trial show a superior survival benefit in patients receiving Medtronic's (NYSE:MDT) CoreValve via transcatheter aortic valve replacement ((TAVR)) compared to those who underwent surgical aortic valve replacement (SAVR). This is the first study to demonstrate statistically significant survival differences favoring TAVR in aortic stenosis (narrowing of the aorta) patients who are considered high risk for surgery.
- At two years, all-cause mortality in the TAVR cohort was 22.2% compared to 28.6% in the SAVR group (p=0.04). The absolute difference in all-cause mortality between the two cohorts increased from 4.8% at Year One to 6.5% at Year Two.
- The rate of stroke in the TAVR group was 10.9% versus 16.6% in the SAVR group (p=0.05). The major stroke rates were 6.8% and 9.8%, respectively, but the results were not statistically significant (p=0.25). The combined endpoint of all-cause mortality or major stroke favored TAVR (24.2% versus 32.5%, p=0.01).
- Investigator Michael Reardon, M.D., says, "In this trial CoreValve maintains a low and stable stroke rate and the recovery advantages CoreValve demonstrated at one year are maintained at two years. Current ACC/AHA guidelines refer to TAVR as a reasonable alternative to SAVR in high risk patients as judged by the heart team, however these clinical data suggest a change in these guidelines may be warranted for the self-expanding valve in this patient population."
- The data were presented the 64th Annual Scientific Session of the American College of Cardiology.
Mar. 12, 2015, 10:46 AM
- Medtronic (MDT +0.5%) commences a clinical study of its Resolute Onyx drug-eluting stent (DES) in the U.S. in patients with coronary artery disease. The first phase will target patients with small vessels that will require a 2.0 mm stent, which are often untreatable with a DES. Core sizes of the stents will be studied separately.
- Principle investigator Roxana Mehran, M.D., from New York's Mount Sinai School of Medicine says, "One of the biggest challenges we face as interventional cardiologists is treating small, diseased coronary arteries, a common condition seen frequently in patients with diabetes. The initiation of the Resolute Onyx DES with CoreWire Technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions."
- CoreWire Technology builds on the stent manufacturing method called Continuous Sinusoid Technology which molds a single strand of wire into a sinusoidal wave that enables a continuous range of motion. The wire has a denser core surrounded by a cobalt alloy outer layer. This enables the stent to have better visibility during the procedure and, with thinner struts, improved deliverability while maintaining its radial and longitudinal strength.
- The Resolute Onyx DES was CE Mark-cleared in Europe in November. It remains investigational in the U.S.
Mar. 3, 2015, 9:38 AM
- A federal appeals court overturns a $102M jury award to Medtronic (MDT -0.8%) in a long-running patent dispute with NuVasive (NUVA +0.4%) pertaining to spinal implants.
- A jury awarded damages to Medtronic in 2011 after it found that NuVasive's CoRoent XL implants, MaXcess II and III retractors and Helix mini anterior cervical plates violated three Medtronic patents.
- The appeals panel upheld the jury's finding of liability but determined that the damage award was improper because Medtronic is not permitted to recover damages for lost profits or for the sale of conveyed products.
- Medtronic has yet to comment on the situation.
Feb. 24, 2015, 9:43 AM
- The FDA grants 510(k) clearance to privately-held Bioness' StimRouter, an implantable neuromodulation device for the treatment of chronic pain of peripheral nerve origin. It is the first implanted device with a specific indication for peripheral nerve stimulation.
- The system consists of an implanted lead , an external pulse transmitter and conductive electrode and a small hand-held wireless control unit.
- Bioness is yet another medical products firm started by serial entrepreneur Al Mann, the force behind Second Sight Medical Products (EYES +21.3%), MannKind (MNKD -1%), Advanced Bionics and MiniMed.
- Neuromodulation-related tickers: (MDT -0.3%)(STJ -1.9%)(BSX)(NURO)
Medtronic PLC is engaged in providing medical technology alleviating pain, restoring health, and extending life of people. It currently functions in three operating segments that manufacture and sell device-based medical therapies.
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