HeartShield prevents heart rupture by acting as a protective barrier between the heart and the thoracic wall during negative pressure wound therapy for deep sternal wound infection. The device consists of several interfitting components: a T-shaped plastic disc with ridge, a foam sleeve with a plastic wound contact layer, and two foam layers.
During use, the base of the T-shaped plastic disc with ridge is covered with a foam sleeve and inserted into the wound so that the base covers the heart. The central part of the device lies between the sharp edges of the sternum and protrudes above skin-level. Holes in the device allow fluid to be drained from the wound, while the foam layers help maintain device placement and proper closure.
Stage Of Development
The device has been studied in animals and in a limited number of patients and has attained a Technical Readiness Level of 6TRL. Conducted by Drs. Richard Ingemansson, Sandra Lindstedt-Ingemansson, and Malin Malmsjö at Lund University, randomized controlled studies in pigs showed that during treatment with HeartShield, there was no deformation, bleeding, or damage to the heart and lungs, that HeartShield did not compromise heart pumping function, and that HeartShield protected the heart, lungs and cardiovascular structures from damage during negative pressure wound therapy (NPWT).
The same physician-researchers tested the device in a small number of human patients in an ethically-approved research study at Lund University entitled ”Protection of the Heart during Negative Pressure Wound Therapy in the Chest Cavity.” This research showed that in comparison to standard NPWT, patients treated with HeartShield showed a decreased risk of damage to the heart, faster decrease in C-reactive protein levels and leukocyte counts, earlier bacterial clearance, and a significant reduction in the required duration of NPWT. These results suggest that the device not only prevents bleeding during NPWT but also leads to more rapid healing of the infected thoracic cavity, possibly due to increased drainage capacity.
HeartShield, will team with Lund University to undertake a clinical investigation of HeartShield designed to generate scientific and clinical data necessary to support device regulatory approval. This clinical investigation will take place at Lund University/ Skåne University Hospital, Department of Cardiothoracic Surgery, under the lead of Dr. Richard Ingemansson, who conducted the previously-cited HeartShield studies. The general objectives will be to document the safety and performance of HeartShield according to Class III Medical Device regulatory requirements. This will involve substantiating that HeartShield is safe under normal conditions of use, evaluating any side-effects, and confirming an acceptable benefit/risk ratio.
Specific investigation end points will focus on (i) signs of bleedings from the mediastinum and its organs; (ii) signs of epicardial petechial bleedings on the heart (iii) signs of callus formation on the right chamber of the heart (iv) total treatment time and (v) C-reactive protein levels. Twenty patients in total will be enrolled, with half randomly assigned to a control group and treated according to standard NPWT protocol, and the other half treated with HeartShield during NPWT. In general, patients treated with NPWT because of DSWI following cardiac surgery will be eligible for the study, with specific exclusion criteria to be determined before study start.
Without negative pressure
With negative pressure
With negative pressure
With negative pressure
Rigid barrier for protection
ShiedlHeart ahs further developed and implemented the production process for the device and is able to perform manufacturing under GMP and ISO 13485 at the approved facility in Kristianstad, Sweden.
Potential areas where further development opportunities can be turned into commercial value are for instance for VesselShield and GutShield.
Intellectual Property Portfolio
With a very strong patent portfolio, including seven granted patents and a further twelve pending applications, Shieldheart is well-positioned to find out-licensing partners. In addition, Shieldheart’s freedom to operate investigations support that nothing hinders it from marketing worldwide. While there is a potentially competing patent in the U.S. for a portable negative pressure wound therapy device, it is not indicated for preventing iatrogenic injury and is not considered a material threat.
HeartShield should be targeted to cardiac surgeons and healthcare systems. Cardiac surgeons are the intended end-users of the product and are expected to embrace HeartShield as an innovative solution to a serious patient-care problem. Similarly, healthcare systems are expected to react positively to evidence that HeartShield reduces serious post-surgical complications and time to healing.