Medtronic, start-ups vie to debut leadless pacemakers

MedCity News logo

Medtronic Inc. (NYSE:MDT) is quietly working on plans to develop a pacemaker that can deliver electricity to the heart without wires.

The Fridley, Minn.-based company confirmed to MedCity News that it’s building a leadless pacemaker but offered no further details on the device, which reportedly can be implanted directly into the right ventricle.

Several medical device firms have been pursuing leadless cardiac devices in recent years.

San Clemente, Calif.-based Nanostim Inc. is also working on a wireless pacemaker system that protects the heart in case the device pops loose.

Sunnyvale, Calif.-based EBR Systems Inc. is developing a system that uses ultrasound to activate a tiny device in the heart that converts the acoustic energy into electricity. Eden Prairie, Minn.-based Split Rock Partners, an early stage venture capital firm, is a major investor in EBR Systems. The start-up was co-founded by former Medtronic director of engineering Richard Riley.

In May, San Clemente-based Cameron Health Inc. announced promising results from a clinical study testing the first-of-its-kind implantable cardioverter defibrillator subcantaneous system that avoids the traditional method of snaking leads through veins. Boston Scientific Inc. (NYSE:BSX) is an investor in Cameron.

That Medtronic, the world’s largest medical device maker, should embrace leadless devices represents a remarkable shift not only for the company but for the industry as well. For years, medical device makers raced to develop smaller and thinner leads, which allowed surgeons to implant devices with greater ease and flexibility.

Medtronic has spent several years and millions of dollars to develop its next generation Sprint Fidelis leads. In 2007, however, the company stopped selling the lead after reports the wire broke apart inside the body. Countless lawsuits from investors and patients followed, culminating in a Supreme Court decision that ruled Medtronic could not be held liable for a device that met the FDA’s regulatory standards.

Earlier this year, Medtronic told doctors that lead failures may have factored into at least 13 deaths. Up to this point, surgeons have implanted about 260,000 Sprint Fidelis leads in patients in the U.S., with 143,000 still active. Leads can’t be easily removed, which is why Medtronic had advised patients to leave them in.

A report by UBS Investment Research said lead failures could accelerate over time, citing independent studies that predict failure rates could hit 30 percent by four years. Medtronic’s own data suggests a 3 percent failure rate at three years. The report said "fidelis may cast a long shadow"
over the $5 billion ICD market.

Wireless devices could go a long way in easing the worries of nervous patients. Plus implanting the devices without threading wires through the veins would lower the cost of the surgery, said Charles Huff, an analyst with Dougherty & Co., an Minneapolis-based investment bank.

It’s probably no accident that Medtronic is starting with the pacemaker — an ICD is a significantly more complicated device. But implanting the pacemaker directly into the heart presents its own safety problems if the device breaks loose.

“The potential of detachment of the leadless biostimulator from the implant site would represent an immediately serious event, as for example, a pacemaker lost from the right ventricle can exit the heart via the pulmonic valve and lodge in the lung,” according to documents Nanostim filed with the U.S. Patent and Trademark Office.

Nanostim is working on a system that would feature “secondary fixation,” a tether made from biomaterials that would further secure the device to the heart and “prevent escape of the pacemaker into the circulation downstream from the heart.”

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Leave a Reply