Sun, Jun. 14, 10:41 AM
- The FDA approves St. Jude Medical's (NYSE:STJ) Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson's disease (PD) and essential tremor in patients who have had inadequate responses to medication.
- The device consists of a battery-powered rechargeable electrical pulse generator that is implanted under the skin of the upper chest with lead wires that attach to electrodes placed in the brain. The pulse generator, which can be adjusted, delivers low intensity electrical pulses to target areas in the brain.
- Approximately 1M Americans live with PD while several million are affected with essential tremor.
- Brio is the second neurostimulator cleared for PD and essential tremor. The FDA approved Medtronic's (NYSE:MDT) Activa Deep Brain Stimulation Therapy System in 1997 for the treatment of tremor associated with essential tremor and PD. In 2002, the agency approved a label expansion to include the symptoms of PD.
Fri, Jun. 5, 8:33 AM
- The FDA approves Medtronic's (NYSE:MDT) MiniMed Connect, a system that enables diabetic patients to view their insulin pump and continuous glucose monitor data on a smartphone. It also enables remote monitoring and text message notifications and provides clinicians with convenient access to more comprehensive patient data.
- MiniMed Connect consists of a small device that can fit on a keychain or in a pocket, a smartphone app and web display on a desktop or mobile device.
Tue, Jun. 2, 8:00 AM
- Medtronic (NYSE:MDT) fiscal Q4 results ($M): Revenues: 7,304 (+60.0%); Cardiac Rhythm & Heart Failure: 1,398 (+3.9%); Coronary & Structural Heart: 792 (+1.1%); Aortic & Peripheral Vascular: 406 (+69.2%); Cardiac & Vascular Group: 2,596 (+9.6%); Minimally Invasive Therapies Group: 2,387; Surgical Solutions: 1,293; Patient Monitoring & Recovery: 1,094; Spine: 743 (-5.5%); Neuromodulation: 518 (+1.0%); Surgical Technologies: 461 (+5.3%); Neurovascular: 132; Restorative Therapies: 1,854 (+6.7%); Diabetes Group: 467 (+1.5%).
- Net Income: -1 (-100.2%); EPS: 0.00 (-100.0%); CF Ops: 1,912 (+44.0%).
- Fiscal 2016 Guidance: Revenue growth: 4 - 6%; Non-GAAP EPS: $4.30 - 4.40.
- Fiscal Q1 Guidance: Non-GAAP EPS: $1.08 - 1.13.
Tue, Jun. 2, 7:25 AM
Mon, Jun. 1, 5:30 PM
Tue, May 26, 12:03 PM
- China's medical device market, forecasted to grow to $18B by 2018, represents a key growth driver for Medtronic (MDT -1%) says CEO Omar Ishrak. To that aim, the company is expanding the number of low-cost products its sells there while it explores potential acquisitions of China-based device makers.
- Mr. Ishrak says, "We're completely bullish on China. It's a numbers game. This will be the largest market and it's not a debate. It's a matter of when."
- The firm intends to increase its annual top-line growth in emerging markets to 15% from today's 12%. According to London-based consulting firm L.E.K., China will become the world's third-largest medical device market in 2018, displacing Germany and behind the U.S. and Japan.
- Chinese authorities have pressured medical companies to cut prices. Low- and mid-range-priced products now constitute ~70% of the market, up substantially from a decade ago when premium-priced devices dominated. Domestic makers now control 80% of the drug-eluting stent market, one reason Medtronic is assessing acquisition opportunities.
- The company currently owns Covidien, which has a large presence in China, and Chinese orthopedic implant maker China Kanghui Holdings.
Tue, May 19, 9:03 AM
- Medtronic (NYSE:MDT) preliminary Q4 results ($M): Total Revenues: 7,302 (+59.9%); Cardiac Rhythm & Heart Failure: 1,398 (+3.9%); Coronary & Structural Heart: 792 (+1.1%); Aortic & Peripheral Vascular: 406 (+69.2%); Cardiac & Vascular Group: 2,596 (+9.6%); Minimally Invasive Therapies Group: 2,385; Spine: 743 (-5.5%); Neuromodulation: 518 (+1.0%); Surgical Technologies: 461 (+5.3%); Neurovascular: 132; Restorative Therapies Group: 1,854 (+6.7%); Diabetes Group: 467 (+1.5%).
- This is the first quarter that includes Covidien so final results will be reported two weeks later than normal on June 2.
Tue, May 12, 10:37 AM
- The FDA approves Medtronic's (MDT -0.8%) Arctic Front Advance ST Cryoablation Catheter for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF). The device, which uses coolant rather than heat, is used to isolate the pulmonary veins, which are the source of erratic electrical signals that cause AF.
- The product also has CE Mark clearance in Europe for the treatment of AF.
Sun, May 10, 6:46 PM
- The FDA approves Nevro's (NYSE:NVRO) Senza spinal cord stimulation system (NYSE:SCS) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza system's value proposition is the reduction of pain without paresthesia or tingling sensation, which typically characterizes SCS therapy and that many patients find uncomfortable. Senza avoids paresthesia by delivering high frequency stimulation (10 KHz) and low stimulation amplitudes.
- The FDA also clears Senza for stimulation below 10KHz, which requires paresthesia.
- Related tickers: (NYSE:MDT) (NYSE:BSX) (NYSE:STJ)
Tue, May 5, 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.
Mon, May 4, 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.
Wed, Apr. 22, 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.
Tue, Apr. 14, 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.
Mon, Apr. 13, 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."
Mon, Apr. 13, 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).
Thu, Apr. 2, 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.
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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