The Contour Neurovascular System™ is used for the treatment of intracranial aneurysms. The Contour Neurovascular System ™ is a unique, fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. Commercial sales, via a controlled market release across the European Union (EU), are expected to begin during the second quarter of 2020.

CE Mark approval was based on data generated from the company’s two EU studies evaluating the safety and efficacy of the Contour Neurovascular System™, focusing on unruptured intracranial aneurysms. The latest, completed in 2019, was conducted at six sites in Germany, Austria, and Denmark, while the earlier study included four sites in the United Kingdom and Hungary. Data from the first study has been presented at a number of scientific conferences in early 2020, while data from the second, most recent study will be presented later this year.

“As our clinical data experience grows, and more physicians use the System, results continue to be compelling – providing additional confirmation that the Contour Neurovascular System™ delivers an important clinical option and represents a new, and potentially disruptive, standalone solution for the treatment of bifurcated saccular intracranial aneurysms compared to currently available technologies,” stated Dr. Stephen Griffin, President of Cerus Endovascular. “Importantly, physicians who have used the System have highlighted the benefits inherent in its unique simplicity, including a simple sizing approach of the device to the aneurysm width, ease of deliverability and controlled deployment.”

“Congratulations go out to the entire company, including our new management team, who were instrumental in pushing these studies forward, leading to our first regulatory approval and the achievement of a number of other, as yet unannounced, key milestones,” stated Dr. Sam Milstein, Chairman of Cerus Endovascular. “CE Mark approval, a critical step in our go-to-market strategy, has propelled us from the research and development stage to a  commercial-stage company, and we are eager to begin this next phase by making the Contour Neurovascular System™ available to physicians and patients across the EU in a controlled roll-out.”

Abbott reports the devices offer new opportunities for patient engagement and remote monitoring through new smartphone connectivity and connected applications. Additional benefits include a patient preferred design, improved battery longevity, and MRI compatibility.

Abbott notes doctors will often recommend ICDs for the prevention of sudden cardiac death in patients who suffer from reduced cardiac function and who may be at risk of suffering from life-threatening abnormal heart rhythms. These abnormal rhythms, also known as ventricular arrhythmias, can occur when the heart beats too fast or chaotically leaving the heart unable to pump blood effectively. CRT-Ds are used to prevent sudden death similar to traditional ICDs, but in addition, act to restore the normal timing of the ventricles or lower chambers of the heart in patients with reduced cardiac function and progressive heart failure despite optimal medical therapy.

The new Gallant system pairs with Abbott’s secure myMerlinPulse™ mobile app to help streamline communication and increase engagement between doctors and their patients. For example, the app allows patients to engage more frequently with their healthcare team by providing access to transmission history and device performance, and the app can prompt patients to schedule their next appointment. Through the myMerlinPulse app, physicians can monitor their patients remotely, allowing for the identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.

“The positive impact of remote monitoring has been proven repeatedly and leads to better patient outcomes and reduced burden on the healthcare system,” said Avi Fischer, M.D., divisional vice president, and chief medical officer for Abbott’s Cardiac Rhythm Management business. “Abbott’s new Gallant system provides people the ability to connect to their doctor anytime, even while away from home, and reinforces our commitment to incorporate advanced technologies that will help improve engagement between patients, caregivers, and doctors.”

In addition to enhanced remote monitoring capabilities, the Gallant CRT-D system includes Abbott’s MultiPoint™ Pacing and SyncAV features to help more patients respond to CRT therapy. Also, the Gallant ICD device includes Abbott’s TailoredTherapy™ suite to help physicians more intuitively program their patient’s devices. By incorporating these features into the Gallant systems, Abbott continues to prioritize therapy built around a patient’s specific programming needs to ensure they respond to treatment in the most effective way.

Abbott has designed Gallant with a secure lifecycle approach, which includes using the latest cybersecurity controls and partnering with industry cybersecurity experts to provide input into the design and testing of these controls.  This approach provides the ability to more seamlessly update the device as cybersecurity threats evolve in the future notes Abbott.

“As I consider the next generation of high voltage therapy, cardiac rhythm management devices have to become more than just a device – they need to fit people’s lifestyles and empower them to be more engaged with their care and more connected to me and my hospital,” said Johannes Sperzel, M.D., head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany, “With Abbott’s new Gallant devices, I can offer my patients smartphone connectivity, powerful connections to their clinical team and improved outcomes through a more tailored therapy approach. The features in Abbott’s devices will propel the industry forward in a very meaningful way.”

Caretaker Medical provides clinical-grade wireless patient monitoring and is the maker of the Caretaker® wearable patient monitor that utilizes a simple Finger Cuff to measure Real-time “Beat by Beat” Continuous Blood Pressure, Respiration Rate, and other hemodynamic parameters, has incorporated VivaLNK’s FDA-Cleared ECG Patch to their wireless patient monitoring platform.

The Caretaker® patient monitor provides clinicians with continuous, uninterrupted Blood Pressure and Vital Signs data across the full continuum of care in a completely wire-free form factor that maximizes patient mobility and provides a comprehensive view of hemodynamic health.  Clinicians can remotely view patient data from virtually anywhere using the Caretaker App, the CaretakerCloud Remote Monitoring Portal, or via data integration with other monitoring platforms.

“Our patented Pulse Decomposition Analysis method of non-invasive hemodynamic measurements like continuous beat-by-beat Blood Pressure provides clinicians with a view of the patient’s mechanical heart function, and VivaLNK’s reusable ECG Patch reveals the status of the patient’s electrical heart function,” said Jeff Pompeo, Caretaker Medical’s President & CEO.  “Combined, the Caretaker monitoring platform now provides a seamless view of both electrical and mechanical heart health, including waveforms, in a completely wire-free, wearable form factor that doesn’t inhibit patient mobility.”

Both the Caretaker wireless monitor and the VivaLNK ECG Patch are FDA-Cleared and CE-Mark certified and available for purchase from Caretaker Medical and its distributors.

In2Bones Global, Inc. today announces the U.S. launch of the Avenger Radial Head™ Prosthesis System for primary and revision joint replacement of the radial head. The new prosthesis restores elbow joint function and provides several advantages to surgeons and patients compared with current prosthetic systems.

In2Bones notes this is the first radial head implant to include sterile, single-use instrumentation.

The modularity of the new Avenger Radial Head Prosthesis System — with multiple, highly-polished head and stem sizes — enables surgeons to restore the appropriate height of the radius, which may aid in elbow stability. The new System is also designed with a smooth stem, shown in multiple long-term studies to provide better clinical outcomes than press-fit, ingrowth radial head implant designs.^{1, 2}

The elbow joint is often difficult to access during surgery due to swelling and inflammation caused by trauma. The Avenger System resolves this with tapered and short stem options, allowing for easier insertion and improved implant stability.

“I choose smooth stem radial head implants for my patients because they have shown to have better long-term results,” says Korsh Jafarnia, M.D., orthopedic surgeon and specialist in the hand and upper extremities at Houston Methodist Orthopedics & Sports Medicine. “The In2Bones Avenger Radial Head System is a modern, smooth stem design that is easier to implant due to the tapered and shorter stems.”

Radial head replacements are often performed during trauma surgery with little advanced notice. Thus, there can be tremendous benefits to providers who select implants that include sterile, single-use instruments. Benefits include:

• Cost savings of as much as $400 per surgery
• Increased efficiencies because long lead times and delays related to on-site sterilizing processes are bypassed
• Reduced risks of surgical site infections (SSIs) post-operatively

“Having the instruments and implants sterile and ready to use provides costs savings for my hospital, and assures me that the system will be ready when I’m called in for surgery,” Dr. Jafarnia notes.

“Currently, radial head implant suppliers ship non-sterile instrument sets nationwide for short-notice cases, which can cause potential delays and can increase costs,” explains Jon Simon, Sr. Vice President of Marketing at In2Bones. “The Avenger Radial Head System can be placed on shelves and be ready for immediate use, on-demand. Additionally, surgeons and caregivers can be assured that the sharp, precision instrumentation will only ever contact one patient.”

References

^1. T. Flinkkilä, T. Kaisto, K. Sirniö, P. Hyvönen, J. Leppilahti, J. of Bone and Joint Surgery, Short- to mid-term results of metallic press-fit radial head arthroplasty in unstable injuries of the elbow. VOL. 94-B, No. 6, JUNE 2012.

^2. Grewal; J. Bone Joint Surg. 2006;88:2192-2200