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Aug. 3, 2015, 10:23 AM
- The U.S. Centers for Medicare and Medicaid Services (CMS) approves a new technology add-on payment for C.R. Bard's (BCR) Lutonix Drug-Coated Balloon (DCB) under the Medicare hospital inpatient prospective payment system to help cover additional costs incurred by hospitals treating Medicare beneficiaries with the product. The maximum add-on payment, which will go into effect on October 1, will be $1,036 when DCBs are used for inpatient peripheral procedures and the total device costs exceed the allowance under existing DRG reimbursement.
- The Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of paclitaxel.
- Update: CMS approves a maximum add-on payment of $1,035.72 for Medtronic's (MDT -0.7%) IN.PACT Admiral DCB.
Jul. 13, 2015, 9:00 AM
- Medtronic (NYSE:MDT) acquires Carlsbad, CA-based RF Surgical Systems for $235M. RF focuses on the detection and prevention of retained surgical items (e.g., sponge, gauze, towel) after surgical procedures. The company's product, designed as an adjunct to manual counting methods, uses low radio frequency to track and detect items embedded with an RF tag.
Jun. 23, 2015, 9:52 AM
- The FDA approves Medtronic's (MDT -0.1%) CoreValve Evolut R System for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis (narrowing) who are at high/extreme risk for surgery. It is the first self-expanding recapturable transcatheter heart valve available in the U.S.
- TAVR is a minimally invasive surgical procedure to repair an old or damaged aortic valve. Instead of opening up the chest and replacing the defective valve, the replacement is wedged in the valve's place via a catheter. When the new valve is expanded it pushes the old valve leaflets out of the way and assumes the job of regulating blood flow.
Jun. 19, 2015, 5:39 PM
- Medtronic (NYSE:MDT) acquires Sunnyvale, CA-based Aptus Endosystems, a privately-held medical device firm developing advanced technology for endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). The transaction value is ~$110M. No additional financial terms are disclosed.
Jun. 19, 2015, 10:54 AM
- Medtronic (MDT +0.6%) acquires Cleveland, OH-based CardioInsight for ~$93M in a debt-free transaction of $75M in cash plus the retirement of an outstanding $25M Medtronic loan less $7M in CardioInsight cash. Additional terms are not disclosed.
- CardioInsight's principal product is the ECVUE system, a non-invasive mapping system for electrical disorders of the heart.
Jun. 19, 2015, 9:55 AM
Jun. 18, 2015, 7:20 AM
- Medtronic (NYSE:MDT) invests in Arsenal Medical subsidiary Arsenal AAA with an option to acquire the firm if certain milestones are achieved. Financial terms are not disclosed.
- Arsenal AAA is developing a proprietary foam and delivery mechanism to treat aneurysms. The foam is designed to stabilize an aneurysm and reduce the risk of an endoleak by filling the aneurysmal sac around an endograft (a stent that is placed inside the thoracic aorta to alleviate the pressure). This is important in type II endoleaks where the anatomy of the branch vessels can cause persistent blood flow within the aneurysmal sac even in the presence of an endograft. Arsenal's foam can be used with any commercially available endograft and allows for the preventive treatment of endoleaks.
Jun. 14, 2015, 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.
Jun. 5, 2015, 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.
Jun. 2, 2015, 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.
Jun. 2, 2015, 7:25 AM
- Medtronic (NYSE:MDT): FQ4 EPS of $1.16 beats by $0.05.
- Revenue of $7.3B (+59.7% Y/Y) beats by $110M.
Jun. 1, 2015, 5:30 PM
May 26, 2015, 12:03 PM
- China's medical device market, forecasted to grow to $18B by 2018, represents a key growth driver for Medtronic (MDT -1%) says CEO Omar Ishrak. To that aim, the company is expanding the number of low-cost products its sells there while it explores potential acquisitions of China-based device makers.
- Mr. Ishrak says, "We're completely bullish on China. It's a numbers game. This will be the largest market and it's not a debate. It's a matter of when."
- The firm intends to increase its annual top-line growth in emerging markets to 15% from today's 12%. According to London-based consulting firm L.E.K., China will become the world's third-largest medical device market in 2018, displacing Germany and behind the U.S. and Japan.
- Chinese authorities have pressured medical companies to cut prices. Low- and mid-range-priced products now constitute ~70% of the market, up substantially from a decade ago when premium-priced devices dominated. Domestic makers now control 80% of the drug-eluting stent market, one reason Medtronic is assessing acquisition opportunities.
- The company currently owns Covidien, which has a large presence in China, and Chinese orthopedic implant maker China Kanghui Holdings.
May 19, 2015, 9:03 AM
- Medtronic (NYSE:MDT) preliminary Q4 results ($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.
May 12, 2015, 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.
May 10, 2015, 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)
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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