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Abiomed Announces Promising Results Of First-in-Human Trial Of PreCARDIA

Results from the VENUS HF first-in-human early feasibility study shows Abiomed’s preCARDIA occlusion device promotes decongestion in patients with acutely decompensated heart failure, the company announced on 12 January.

The preCARDIA system is designed to reduce pressure on the heart and lungs by intermittently occluding the superior vena cava, which gives the heart and kidneys a chance to work more effectively. Abiomed acquired the preCARDIA technology in 2021 when it bought Minnesota-based preCARDIA, Inc. for an undisclosed sum. (Cardiovascular CatchUp Abbott Medtronic Boston Scientific Stay Hot During Summer)

Acutely decompensated heart failure in patients greater than 65 years old is the number one cause of hospitalizations in the US. Acute kidney injury has a significant impact on those patients’ length of stay, Abiomed CEO Michael Minogue said at the J.P. Morgan Healthcare Conference on 12 January.

VENUS HF enrolled 30 acutely decompensated heart failure patients and treated them with the preCARDIA therapy for 12 or 24 hours. The primary endpoint of the trial was a composite of major adverse events through 30 days.

None of the patients in the study suffered major adverse events. On average, the study subjects’ right-atrial pressure decreased 34% from baseline and their pulmonary capillary wedge pressure dropped 27% from baseline. The subjects’ urine output rose by 130% from pre-treatment values and their net fluid output increased by 156% from pre-treatment values, indicating improved kidney function.

The US Food and Drug Administration is reviewing preCARDIA system , which earned FDA’s breakthrough status because it addresses an important unmet need. About 300,000 of the 1 million people treated for acutely decompensated heart failure in the US every year are non-responsive to diuretic drugs and these patients have few viable options for reducing fluid build-up that strains their heart and kidneys.

Minogue also cited STEMI DTU, a randomized trial of Abiomed’s Impella CP temporary circulatory assist device, as an example of Abiomed’s ongoing investment in new indications for its technologies.

STEMI DTU is designed to evaluate if temporary circulatory support with Impella CP for 30 minutes prior to a cardiac catheterization procedure improves the patient’s outcomes. The trial began in 2019 and will yield results in 2023. (Abiomed Manages Pandemic Recovery By Moving Operations Online)

Abiomed hopes the results of STEMI DTU will “fundamentally transform the standard of care for heart attacks.”

Minogue also mentioned PROTECT IV, a study of Impella CP in patients undergoing high-risk coronary interventions, and RECOVER IV, a randomized trial of Impella in patients undergoing an intervention to treat an acute myocardial infarction and cardiogenic shock.

“Our current studies are build off of our prior studies with best practices and clinical publications that demonstrate that Impella technology enables high-risk PCI and improves patient quality of life, improves patient outcomes and survival with heart recovery in cardiogenic shock and provides one of the most cost-effective therapies for insurance companies and Medicare programs with lower length of stay and re-admissions,” Minogue said.

Penumbra Addresses Unmet Needs With Thrombectomy

The potential total addressable market for Penumbra’s mechanical thrombectomy devices totals about 1.16 million patients annually in the US, but only about 20% of those patients are being treated with mechanical thrombectomy, Penumbra CEO Adam Elsesser explained at the J.P. Morgan conference.

The mechanical thrombectomy market is “underpenetrated” because “the innovation that we're [developing] is relatively new,” Elsesser told Medtech Insight that.

“We're off to a good start over the last four or five years and the products have gotten better so now they're even easier to use,” he said. “For those [physicians] who might have been reluctant in the past [to use mechanical thrombectomy], they can think about it and try again, because the products have got better.”

One of the bigger markets Penumbra is going after are patients with acute limb ischemia, which causes pain and disability and may lead to amputation.

Penumbra estimates that about 259,000 people in the US suffer acute limb ischemia every year, but only about 50,000 of them are currently treated with mechanical thrombectomy. The other 80% of these patients are treated with invasive surgery, catheter-directed lytic therapy, or medical management.

Penumbra’s Indigo thrombectomy platform, launched in 2013, allows physicians to remove the clot causing the acute ischemia in a single-treatment session. In March 2021, the company launched the Lightning 7 intelligent aspiration system for Indigo, which uses proprietary algorithms to differentiate between clot and flowing blood.

The company is currently sponsoring the STRIDE study to provide clinical evidence about the utility of Lightning 7 to help salvage limbs, remove clot, and restore blood flow in occluded arteries.

Penumbra is also developing thrombectomy technology, including its Lightning 12 system, to treat deep vein thrombosis, which afflicts at least 351,000 patients in the US each year. Most of these patients are medically managed with anticoagulation or treated with catheter-directed thrombolysis that requires and an overnight stay in an ICU and carries a significant risk of bleeding.

The company’s neurointervention division markets the Red series of aspiration-based mechanical thrombectomy devices for complete thrombus removal in patients who have suffered an ischemic stroke. About 200,000 of these patients in the US each year could benefit from mechanical thrombectomy, but only about a third of them are treated this way “because they are not getting to a hospital that offers neuro-interventional services,” Elsesser said.

“Our goal is to deliver a health care-only, safe [VR] platform that addresses patient engagement, clinical outcomes and patient satisfaction.” – Adam Elsesser

The company is also currently developing the Thunderbolt algorithm for clot removal to treat ischemic stroke and will soon launch a US trial of the system to “show the strong benefits of this paradigm-changing technology,” Elsesser said.

Thunderbolt drives the operation of alternating valves to create a variation in vacuum that facilitates thrombus removal by reducing static friction between the thrombus and the reperfusion catheter, he explained.

About 193,000 patients in the US each year have coronary lesions that have a high thrombus burden, which increases risk of embolization and poor outcomes, but only about 55,000 of these patients are treated with mechanical thrombectomy. Instead, most of them are treated with syringe-based suction devices that have proven to be ineffective, Elsesser said.

To address this unmet need, Penumbra is developing the CAT RX aspiration catheter with a rapid exchange platform to remove significant amount of clot from coronary arteries.

Results of the 400-patient CHEETAH study showed that removing coronary thrombus with CAT RX improves outcomes of coronary interventions in patients with high-thrombus burden coronary vessel occlusions. Results of the study were presented at the Transcatheter Therapeutics (TCT) conference in November by Jay Mathews of the Manatee Memorial Hospital in Bradenton, FL.

The company expects to follow-up CHEETAH with a randomized trial, Elsesser told Medtech Insight.

The Lightning 12 system can also treat high- to intermediate-risk pulmonary embolisms, which afflict about 157,000 patients in the US each year. Less than 10% of pulmonary embolism patients are treated with mechanical thrombectomy, the company estimates.

Results of the 119-patient EXTRACT PE study, completed in 2019, showed aspiration thrombectomy with Penumbra’s Indigo system significantly improved patients’ right ventricle-to-left ventricle diameter ratio, an important predictor of adverse outcomes in patients with pulmonary embolisms.

Penumbra is now sponsoring STRIKE PE, a 600 patient real-world study of Penumbra’s Lightning 12 system in the treatment of pulmonary embolism. The company is also planning a trial comparing pulmonary embolism thrombectomy to medical management.

In 2020, Penumbra announced a new partnership with RapidAI, a Stanford University artificial intelligence spin-off company, to develop clinical and communications modules that will enable faster clinical decision-making in the diagnosis and treatment of pulmonary embolism.

Beyond its thrombectomy business, Penumbra is developing a virtual reality (VR) platform. In September 2021, Penumbra acquired VR-technology company Sixense Enterprises and is developing the Real immersive VR technology for rehabilitation and mental health therapies.

“Our goal is to deliver a healthcare-only, safe [VR] platform that addresses patient engagement, clinical outcomes, and patient satisfaction,” Elsesser said.

Renalytix Looks For FDA De Novo Clearance In 2022

Renalytix expects the US Food and Drug Administration to clear its KidneyIntelX disease prognosis platform via the de novo route in 2022, Renalytix CEO James McCullough said at the J.P. Morgan Healthcare Conference.

FDA granted KidneyIntelX its breakthrough device designation in May 2019. (Renalytix AI And AstraZeneca Collaborate To Improve Chronic Kidney Disease Outcomes)

KindneyIntelX is already being used by a growing number of health systems as a laboratory test to predict patient’s risk of developing chronic kidney disease, and, in April 2021, the US government granted the company a 10-year government-wide acquisition contract to provide KidneyIntelX as a laboratory testing services to the Veterans Administration, Department of Defense, Indian Health Services, and other federal agencies. (Renalytix Collaborates With ADA To Improve Early Detection Of Kidney Disease)

“We're very much interested in looking at drug response and also monitoring therapeutic response and how it affects kidney health in these populations.” – James McCullough

In 2022, the company expects to add 20 more hospital systems to its list of partners.

“We've been getting much better at understanding how to do efficient integration with these large hospital systems,” McCullough said. The company hopes to develop a routine so that it only takes two to three months – from the signing of the contract to the start of live testing – to integrate a new health system partner into the KidneyIntelX platform.

“Coming out of 2022, that will give us access to greater than 1 million diabetic kidney disease patients on an integrated basis through the electronic health record,” he said.

By 2023, the company hopes to add repeat test monitoring and other expanded indications to the KidneyIntelX platform, including assessment of cardiovascular disease.

“Cardiovascular disease and kidney are very closely related and that starts to drive us into the broad population of 40 million Americans with chronic kidney disease,” he explained.

The company is also working with drug companies to help develop and test drugs that treat kidney disease. Results from CANVAS, a 1,325-patient randomized trial of the drug canagliflozin, showed the drug reduced the patients risk score of chronic kidney disease, as measured by KidneyIntelX. Results from CANVAS are now published in the American Journal of Nephrology.

“This is very interesting because there're a whole sequence of new drugs which are entering the market and we're very much interested in looking at drug response and also monitoring therapeutic response and how it affects kidney health in these populations.”

“There is a revolution going on in how to manage [the diabetes] population. It is only growing larger,” he said. “KidneyIntelX and the care model that Renalytix is presenting is [ready] at the right time in the right place.”


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