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InCa - Cardio Watch for Continuous Intra-Cardiac Blood Pressure Sensing

Periodic Reporting for period 1 - InCa (InCa - Cardio Watch for Continuous Intra-Cardiac Blood Pressure Sensing)

Reporting period: 2016-12-01 to 2017-04-30

Congestive Heart failure (CHF) is the leading cause of hospitalizations in patients over 65 years of age. About 1 in 3 patients admitted to hospital will die within one year. Early death of patients and rehospitalization and the associated costs can be reduced dramatically, when the progress of CHF is monitored continuously with a wireless pressure sensor, permanently implanted in the patient’s left heart ventricle or left atrium.

In this 5-month SME-Instruments-Phase-I-Project we focused on evaluating the economic, technical and regulatory feasibility of the production and market implementation of a novel, ultra-small wireless heart pressure sensor for continuous blood pressure management (The “CardioWatch”). For the successful implementation of the project a joint venture is formed by three SMEs with dedicated technologies.

Measuring blood pressure inside the heart is crucial for the early prediction of worsening heart failure and to the proactive management of patients. Being able to monitor and assess intra-cardiac pressure daily and in real-time, in the patient’s home could provide an early warning of potential heart decompensation by allowing for the titration of medications on the basis of reliable physiological data. This will eventually help in decreasing the chance of being admitted to the hospital with heart failure.

The technical feasibility performed in Phase I has shown that it is possible to combine the proprietary technologies of the three SMEs in the fields of novel nanotechnology manufacturing processes, medical technology and microsystems technology to design and prototype ultra-small, safe and cost-efficient miniature devices.
Existing systems for remote monitoring heart failure largely rely on patient’s compliance and subjective assessment of symptoms, vital signs (e.g. blood pressure with cuffs), and daily weight change. However due to their poor sensitivity to detect subtle heart failure changes, these methods have not consistently lowered the rate of heart failure hospitalization.

The new diagnosis platform CardioWatch, propagated by the consortium, solves the major drawbacks of traditional home monitoring by providing frequent, on-demand, real-time telemetric monitoring of vital information that enables proactive patient management of heart failure. Thus, the new technology holds the promise of reducing hospitalizations, improving a patient’s quality of life and delivering more efficient and cost-effective health care.
More information can be obtained from the participants web sites directly:
In this 5 month SME-Phase-I-project we have analyzed the
A: Economic Feasibility,
B: Technical Feasibility
C: Regulatory Feasibly

for the business case of CardioWatch. We summarized the results in a detailed business plan and in an economic and technical feasibility study.

In the Economic Feasibility, we performed a Market Review (market size, market trends and forecast, patent- and market-analysis of competitors, identifying unique features of own solution).
Sources for possible improvements have been identified, e.g. the manufacturing process, to meet the required high-quality levels of a miniaturized, long-term, biocompatible miniature sensor for the human body. These modifications are considered achievable in Phase II, so that the overall feasibility is further improved. Due to the strong positive business forecast and the positive outcome of the technical feasibility this project will be continued.

Detailed business evaluation and structuring of an updated business plan highlights the clinical need and the strong economic feasibility of the implantable sensor. Production cost are well below thresholds to gain proper margins. The implementation of a Quality Management System (QMS) and the First-In-Human-trials necessary for certification and market entry are also considered thoroughly. This led to an expansion of the strategy of market entry preparation and project planning for Phase II.

We have identified our unique selling points (high miniaturization, biocompatibility, patient’s safety, true mobile measurement, low production costs) and reshaped the customer groups analysis.

The potential market entry barriers have been identified, which are for example high regulatory levels for development and production. A Quality Management System (QMS) according to ISO 13485 is required. Therefore, we develop the product in accordance to the QMS already in place within the consortium.

The steps and timeline for certification of the product, including medical trials, CE certification and FDA approval was planned.

During analysation of reimbursement models of the product, reimbursement for even for more expensive devices with less functionality was found. To bring the product into market, a detailed forecast of costs was derived. Profit and loss accounts show Return on Invest shortly after the end of the Phase II project.
We derived basic requirements of the product and the project and formulated Go / Abort criteria for a Phase II project and worked out a detailed plan on actions for a Phase-II project application.

Using miniaturized electronics provided by EvoSense Research & Development GmbH, we have demonstrated, that energy and signal transmission from the outside into the implant, which is located inside a porcine heart, is possible under circumstances reflecting the use in human.

A first production chain for the basic pressure sensing diaphragm was set up. We have demonstrated that by means of novel 3D nanoprinting techniques (Nano3DSense) by the SME Nanoss GmbH ultra-small sensor sizes and minimally invasiveness, high biocompatibility and patient’s safety and inexpensive device production can be achieved.

The technical feasibility shows that the development of the implant with mechanical, electronic and software parts is feasible to costs in good congruence with our business model derived.

The results of this phase I project will be exploited in that way, that we will use them to structure the phase II project, the market entry and an updated business plan for further development. The results of the technical feasibility can be used to further develop a stressable demonstrator, which will be used for public presentations.
The researched statistics emphasize the need to develop and implement more effective strategies to assess, monitor, and treat Congestive heart failure (CHF or HF). Given the considerable, and largely unmitigated burden of CHF, the potential for home monitoring to improve the management of patients with CHF is substantial.

CHF is the progressive weakening of the heart muscle that can occur from a variety of causes, particularly heart attacks and hypertension. Heart failure is characterized by high mortality, frequent hospitalizations and poor quality of life. Nine million deaths in Europe each year are attributed to the disease. The 5-year survival-rate for patients with the diagnosis of CHF is close to 50% (with a poorer prognosis in men than in women), and compares unfavorably with many of the most common cancer diagnoses or HIV/AIDS.

CHF affects 2-3% of the population in industrialized countries with a marked rise in those aged >65. As the ability to keep people from dying from heart attacks has improved, the number of patients living with heart failure has significantly increased over the last 25 years. Despite the dramatic improvements in medical care, heart failure afflicts more than 15 million Europeans (5.8 US Americans) and is the leading cause of hospitalizations with over 3.6 million hospitalizations per year in Europe.

As a consequence of demographic trends, CHF imposes a significant economic burden on patients, their families and western healthcare systems as a whole. This burden is expected to increase in the future due to the ageing population and the introduction of both advanced pharmacological and non-pharmacological treatments, including catheter ablation, device therapy, and monitoring devices for CHF. Frequent hospitalizations are responsible for the largest part of these treatment costs in Europe and worldwide and, thus, are the main target for strategies aiming at cost reduction: In Europe, 5% of all acute hospital admission are CHF related. After discharge, CHF patients are at high risk for rehospitalization or death within 3-month with a rate close to 25%. The estimated annual direct and indirect cost of CHF in 2010 was estimated to be $39.2 billion or 2% of the total health-care budget in the USA only. Evaluations from different European countries indicate a very similar share of CHF-related costs in relation to overall health-care expenditure.

The CardioWatch proposed in this project serves as a key enabler to open up the implant market for the new technology on a wide range. Following the basic implementation (pressure reading, warning, advice for action, automatic transfer to web interface with encrypted data access by the physician) a several times larger aftermarket is expected to grow. IT-structures and services built on top of the basic hard- and software will allow for direct aid-services. Anonymised networked data evaluation gives insight into different characteristics of illnesses and more specific insight into therapy for the individual patient. Different reading devices can be developed to differentiate products with different user interaction and services.

Long-term, continuous pressure monitoring is critically needed for a number of applications, including the monitoring of the intraarterial pressure of patients with hypertension, the intraocular pressure (IOP) of patients with glaucoma, the bladder pressure of patients with neurogenic bladder dysfunction (Figure 15). Real time, continuous bladder pressure information can be used to stimulate the sphincter muscles in an intelligent way, which can be particularly useful for patients with neurogenic bladder dysfunction. A shunt system currently used for hydrocephalus or traumatic brain injury treatment could be more effective with a continuous intracranial pressure feedback.